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24.03.2023 | NEWS

EU MDR/IVDR: New Transitional Provisions Enter into Force

EU MDR/IVDR: New Transitional Provisions Enter into Force

The 6-page amending Regulations (EU) 2023/607 with new transitional provisions for certain medical devices and in vitro diagnostic medical devices was published in the Official Journal of the European Union on 20 March 2023. It entered into force upon publication. This is intended to alleviate supply shortages of important medical devices (we reported). The regulation is binding in its entirety and directly applicable in all member states.


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22.03.2023 | NEWS

FDA: Definition Guidance on Drug Safety in the Supply Chain

FDA: Definition Guidance on Drug Safety in the Supply Chain

On 16 March 2023, the FDA issued its final guidance on detailed definitions around "suspect products" and "illegitimate products".


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17.03.2023 | NEWS

EU-MDR/IVDR: Reassessment of Notified Bodies Only Every 5 Years

EU-MDR/IVDR: Reassessment of Notified Bodies Only Every 5 Years

On 8 March 2023, the European Commission published Delegated Regulations (EU) 2023/502 and 2023/503 to extend the reassessment period for notified bodies under MDR/IVDR to five years. The new time frame has already come into force.


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10.03.2023 | NEWS

EC: General Political Agreement with UK on Northern Ireland Protocol

EC: General Political Agreement with UK on Northern Ireland Protocol

The Northern Ireland question was one of the trickiest open issues in the Brexit negotiations. A general political agreement has now been reached with the so-called "Windsor Framework": The European Commission and the government of the United Kingdom have put together a comprehensive package of solutions to reconcile the movement of goods to Northern Ireland while ensuring effective protective measures for the EU's internal market. The Windsor Framework is to replace the previous Northern Ireland Protocol in the future. The legally binding adoption is pending.


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06.03.2023 | NEWS

FDA: ICH Q13 Guideline and Artificial Intelligence in Drug Manufacturing

FDA: ICH Q13 Guideline and Artificial Intelligence in Drug Manufacturing

On 1 March 2023, the final ICH Guideline Q13 on continuous manufacturing (CM) of active pharmaceutical ingredients and drug products was published by the FDA. In addition to the guidance, the agency also issued a discussion paper on AI for stakeholders' comments. With these publications, the FDA aims to facilitate the adoption of advanced manufacturing technologies for the pharmaceutical industry.


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03.03.2023 | NEWS

EU-MDR: European Parliament Votes in Favour of New Transition Periods

EU-MDR: European Parliament Votes in Favour of New Transition Periods

On 16 February 2023, the European Parliament voted positively to extend the deadline for the certification of medical devices under the EU Medical Devices Regulation (MDR). In January, the deadline extension was proposed by the European Commission to prevent massive supply shortages. Not enough Notified Bodies are available for the recertification of many medical devices, as a requirement of the MDR.


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27.02.2023 | NEWS

EMA: Q&A for Cannabis-Derived Medicinal Products

EMA: Q&A for Cannabis-Derived Medicinal Products

The EMA has published a question and answer document on the regulatory requirements for the authorisation of Cannabis-derived medicinal products in the EU and the work of the Committee for Herbal Medicinal Products (HMPC) in relation to medicinal plant monographs. This was considered useful as those involved in the production of Cannabis products often have little experience of the EU regulatory system for medicinal products.


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09.02.2023 | NEWS

Swissmedic: Validity of GMP Certificates

Swissmedic: Validity of GMP Certificates

Swissmedic announced on 23 January that companies with a valid manufacturing licence for the manufacture of medicinal products can apply for a GMP certificate. The certificates do not contain a validity date, but the date of the GMP inspection.


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09.02.2023 | NEWS

EMA: ICH Guideline Q9 (R1) on Quality Risk Management – Step 5

EMA: ICH Guideline Q9 (R1) on Quality Risk Management – Step 5

On February 6th, 2023, the European Medicines Agency (EMA) published the first revision of the guideline "ICH Guideline Q9 (R1) on Quality Risk Management (QRM) Step 5".

The 27-page document includes "principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.“


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03.02.2023 | NEWS

PIC/S: Publication of New GDP Guidance Documents

PIC/S: Publication of New GDP Guidance Documents

PIC/S has published the following two guidance documents for GDP inspectors: an ‘Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain’ (PI 044-1) and a ‘Questions & Answers (Q&A) document regarding the PIC/S GDP Guide’ (PS/INF 22/2017).


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02.02.2023 | NEWS

EMA: Use of CTIS mandatory in the EU

EMA: Use of CTIS mandatory in the EU

As we already reported in December 2022, the use of the Clinical Trials Information System (CTIS) is now obligatory in the EU.


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27.01.2023 | NEWS

ICH: Final Publication of Revised ICH Q9 Guideline

ICH: Final Publication of Revised ICH Q9 Guideline

The International Council for Harmonisation (ICH) published a revised version of its Q9 guideline on 20 January, updating the original guideline, which is now 18 years old.


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26.01.2023 | NEWS

USA: Transition to ISO 13485 is getting closer

USA: Transition to ISO 13485 is getting closer

The US government's Office of Information and Regulatory Affairs has issued a timeline for harmonizing, or converting, the 21 CFR 820 with the European ISO 13485 for medical devices.


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20.01.2023 | NEWS

FDA: Mutual Recognition Agreement with Swissmedic

FDA: Mutual Recognition Agreement with Swissmedic

On 12 January 2023, the FDA signed a Mutual Recognition Agreement between the United States and Switzerland, allowing the FDA and Swissmedic to share each other's GMP inspectional findings, which will reduce unnecessary costs and duplicative efforts.


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13.01.2023 | NEWS

EMA: ICH Q13 on Continuous Manufacturing Adopted

EMA: ICH Q13 on Continuous Manufacturing Adopted

The European Medicines Agency (EMA) has adopted the ICH guidance on the continuous manufacturing of drug substances and drug products which marks the Step 5 process of document adoption by the Regulatory Members of the ICH Assembly. The document was released on 6 January 2023 and will come into effect on 10 July 2023.


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13.01.2023 | NEWS

EMA: Update on GDP-Q&As for Broker Activities

EMA: Update on GDP-Q&As for Broker Activities

The EMA added two good distribution practice (GDP) questions to its Q&A section on GMP/GDP topics in early January 2023. They should clarify how the GDP rules apply to brokers operating outside the European Economic Area (EEA).


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19.12.2022 | NEWS

EMA: Clinical Trials Information System CTIS mandatory in 2023

EMA: Clinical Trials Information System CTIS mandatory in 2023

As of 31 January 2023, using the new Clinical Trials Information System (CTIS) will become mandatory. CTIS serves as a single entry point of contact for the submission and assessment of clinical trial data in all EU and EEA countries. This facilitates the daily business of sponsors in the EU immensely. In the past sponsors had to submit clinical trial applications separately to competent national authorities (NCAs) and ethics committees in each European country to gain regulatory approval. Publication of the trial information is built into the system, as well.


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09.12.2022 | NEWS

EC: Position Paper on 'Hybrid Audits'

EC: Position Paper on 'Hybrid Audits'

The European Commission's Medical Device Coordination Group (MDCG) published a definition on ‘hybrid audits’ in early December.

The document gives notified bodies some flexibility regarding the duration of physical presence during audits under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR).


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02.12.2022 | NEWS

ICH: Final Q13 Guideline on Continuous Manufacturing

ICH: Final Q13 Guideline on Continuous Manufacturing

In Mid-November, the ICH Q13 Guideline on "Continuous Manufacturing of Drug Substances and Drug Products (Step 4)" was finally adopted during the General Assembly of the International Council for Harmonisation (ICH). With the adoption within the ICH organization, the guidelines are considered harmonized and thus represent the current state of science and technology. A concept paper for the Guideline was first submitted in November 2018.


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02.12.2022 | NEWS

EC: Changed Labelling Requirements for IMPs

EC: Changed Labelling Requirements for IMPs

With the publication of Delegated Regulation 2022/2239, the European Commission has released the revised and amended labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation (CTR). This eliminates the need to retroactively label the expiration date on the primary packaging of unapproved investigational products for which new stability and shelf-life data become available over time.


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18.11.2022 | NEWS

Access Consortium: Recognition Arrangement in GMP Inspections

Access Consortium: Recognition Arrangement in GMP Inspections

The Access Consortium is a collaborative initiative of like-minded, medium-sized regulators from Australia, Canada, Singapore, Switzerland, and the United Kingdom.


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18.11.2022 | NEWS

EMA: Concept Paper on the Revision of EU GMP Annex 11 on Computerised Systems

EMA: Concept Paper on the Revision of EU GMP Annex 11 on Computerised Systems

On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 "Computerised Systems". The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA.


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11.11.2022 | NEWS

MHRA: Resumption of International GMP Inspections

MHRA: Resumption of International GMP Inspections

On 8 November 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a blog post announcing the resumption of international on-site inspections.
Important to know: Notwithstanding, the ‘expiry’ of GMP certificates issued by the MHRA will again be extended until the end of 2023.


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03.11.2022 | NEWS

MHRA: Implementation of British Medical Device Regulation Delayed

MHRA: Implementation of British Medical Device Regulation Delayed

On 25 October 2022, the UK Regulatory Agency MHRA, announced that the introduction of the future UK Medical Device Regulation will be delayed by twelve months. The intended date for introduction of the new and standalone regulation is now set for July 2024.


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28.10.2022 | NEWS

EMA: Updated Q&A on GMP/GDP Topics

EMA: Updated Q&A on GMP/GDP Topics

The European Medicines Agency (EMA) answers frequently asked GMP/GDP questions discussed in the GMP/GDP Inspectors Working Group in its Guidance on good manufacturing practice and good distribution practice: Questions and answers. The document is continuously revised, as last in October 2022. The answers are intended to provide additional clarification to the current EU GMP and GDP regulation.


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28.10.2022 | NEWS

EMA: Updated Q&A on Nitrosamines

EMA: Updated Q&A on Nitrosamines

The European Medicines Agency (EMA) has published a revised version 12 of its Q&A on nitrosamines for marketing authorisation holders dated 10 October 2022. The revision includes an update of Q&A 10 on the limits for nitrosamines in medicinal products and introduces a new Q&A 21 on the approach to control presence of nitrosamine while the AI is being established.


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20.10.2022 | NEWS

TGA: Draft guidance on boundary and combination products

TGA: Draft guidance on boundary and combination products

On 08. October 2022, the Australian Therapeutic Goods Administration (TGA), published the draft guidance 'Boundary and combination products - medicines, medical devices, and biologicals’. The current guidance originally dates back to 2005. Since then, there have been significant changes in the regulation of therapeutic goods.


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14.10.2022 | NEWS

EU: New Data Quality Framework for Medicines Regulation

EU: New Data Quality Framework for Medicines Regulation

On 10 October 2022, the EMA published a 24-pages document on data quality (DQ) framework, which is open for consultation until 18 November 2022. As the topic of data quality and data overall becomes more and more critical to regulating medicinal products, a Data Quality Framework for EU medicines regulation is a logical consequence to provide a unitary approach. Thus, the amount of data that digitalisation brings along not only opens up new possibilities, but also increasingly complex data landscapes.


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14.10.2022 | NEWS

ICH: The Draft Guideline Q5A(R2) Reaches Step 2

ICH: The Draft Guideline Q5A(R2) Reaches Step 2

On 11 October 2022, the ICH published the revised Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin as Step 2 document. This guideline addresses the testing and evaluation of the viral safety of biotechnology products and explains what data should be provided in the application dossier for the marketing and registration of these products.


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07.10.2022 | NEWS

MHRA: Extended use of EC Decision Reliance Procedure across Great Britain

MHRA: Extended use of EC Decision Reliance Procedure across Great Britain

On 30 September 2022 the MHRA informed that the use of the European Commission Decision Reliance Procedure (ECDRP) for Great Britain has been extended for another 12 months until 31 December 2023. The procedure allows a company to submit a product that has received approval from the EMA directly to the MHRA. The MHRA can then grant a license with a shorter review than normally conducted, relying on the EMA’s decision.


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07.10.2022 | NEWS

MHRA: DEKRA appointed first new UK Approved Body to certify medical devices since Brexit

MHRA: DEKRA appointed first new UK Approved Body to certify medical devices since Brexit

DEKRA Certification UK Ltd has become the first organisation after Brexit to complete the new designation process that any potential organisation must go through to become approved to certify medical devices in the UK. With this step taken it is now designated as a UK approved body to undertake assessments for general medical devices (known as Part II designation) and has joined the three current UK Approved Bodies BSI Assurance UK Ltd, SGS United Kingdom Ltd, and UL International (UK) Ltd. These three bodies had been approved before Brexit.


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30.09.2022 | NEWS

USP: Draft for a Cannabis Monograph

USP: Draft for a Cannabis Monograph

The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence Monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally. 


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23.09.2022 | NEWS

EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides

EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides

The European Medicines Agency (EMA) plans to establish clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides. This week, EMA published new concept papers, explaining current requirements on impurities testing, specifications and the control of DNA-reactive chemicals either partly or fully exclude synthetic peptides and oligonucleotides.


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23.09.2022 | NEWS

PIC/S: Publication of Revised GMP Annex 1

PIC/S: Publication of Revised GMP Annex 1

The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).


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19.09.2022 | NEWS

EC: MDR, IVDR Manual on Borderline Devices

EC: MDR, IVDR Manual on Borderline Devices

The European Borderline and Classification Working Group (BCWG), a sub-group of the Medical Device Coordination Group, has created a manual for determining whether a product is classed as a medical device under the new regulations MDR and IVDR. BCWG developed the document as part of an attempt to prevent member states from having different interpretations of the legislation.


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09.09.2022 | NEWS

PMDA: English Version on Procedure for Remote Inspections Revised

PMDA: English Version on Procedure for Remote Inspections Revised

The PMDA (Japanese Pharmaceuticals and Medical Devices Agency) published the English translation of the revised document on remote inspections, Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products. The document describes the specific procedure for a remote inspection and how to organize, prepare and share the necessary paperwork for remote assessment by PMDA (we reported).


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09.09.2022 | NEWS

EMA: Comments on Draft ICH Q2(R2) and ICH Q14 Published

EMA: Comments on Draft ICH Q2(R2) and ICH Q14 Published

On 24 August 2022 the EMA (European Medicines Agency) published a 72-pages strong overview on the comments received as feedback on the draft of ICH Q2 Validation of analytical procedures along with a 54-pages PDF on comments made regarding the draft of ICH Q14 Analytical procedure development. The volume of the documents indicates the large number of comments that were submitted.


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26.08.2022 | NEWS

EC: Long-awaited EU Annex 1 on Sterile Manufacturing Published

EC: Long-awaited EU Annex 1 on Sterile Manufacturing Published

The long-awaited final version of the new EU Annex 1 "Manufacture of Sterile Medicinal Products" was published on 25 August 2022. The deadline for entry into force is 25 August 2023. Regarding section 8.123 on freeze-drying and product transfer, the deadline for entry into force is two years from now and will thus become mandatory on 25 August 2024:


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12.08.2022 | NEWS

FDA: Remote Inspections Will Remain Regular

FDA: Remote Inspections Will Remain Regular

One thing is certain: The FDA’s utilizing remote regulatory assessment is here to stay and remain a regular tool to support onsite inspections. This was addressed by FDA Commissioner Robert Califf and his associate Commissioner for Regulatory Affairs, Judith McMeekin, in a statement released end of July.


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05.08.2022 | NEWS

CHMP: Extended Deadline for Nitrosamine Step 3 Revision and Q&A update

CHMP: Extended Deadline for Nitrosamine Step 3 Revision and Q&A update

The Committee for Medicinal Products for Human Use (CHMP) and the CMDh (Coordination Group on Mutual Recognition Procedures and Decentralised Procedures) of the EMA extended the deadline for submission of variation applications under Step 3: "Variation of marketing authorisation for chemical medicinal products" from 26 September 2022 to 1 October 2023.


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29.07.2022 | NEWS

PANGEA XV: Worldwide Campaign against Falsified and Illegally Imported Medicinal Products

PANGEA XV: Worldwide Campaign against Falsified and Illegally Imported Medicinal Products

From 23 to 30 June 2022, Interpol conducted its 15th globally coordinated operation PANGEA against the illegal online trade of medicines. From fake COVID-19 tests to doping substances or narcotics, the range of illegal shipments was broad.


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29.07.2022 | NEWS

EMA: Concept Paper on Active Substances and Nitrosamine Impurities

EMA: Concept Paper on Active Substances and Nitrosamine Impurities

On 26 July 2022, the EMA published a concept paper to start the process for the revision of the Guideline on the chemistry of active substances. The document dates from 2016 and does not consider the nitrosamine issue that has developed in recent years.


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22.07.2022 | NEWS

EDQM: Implementation of the 11th Edition of Ph. Eur. – Notification for CEP Holders

EDQM: Implementation of the 11th Edition of Ph. Eur. – Notification for CEP Holders

The EDQM informs that the 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2023, and to follow the instructions that the EDQM provides.


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15.07.2022 | NEWS

EC: Q&A on Nitrosamine Impurities updated

EC: Q&A on Nitrosamine Impurities updated

For the third time in a row, the European Commission has updated its Q&A on nitrosamine impurities (we reported). Version 10 was published on 23 June 2022. Questions 5, 10 and 14 have been revised. What is new?


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15.07.2022 | NEWS

EC: Version 20 of Q&A on Safety Features

EC: Version 20 of Q&A on Safety Features

In June 2022, the European Commission published the Question & Answers document on safety features for medicinal products for human use in version 20, coming along with one new Q&A on UI verification of authenticity.

The newly added question 5.14 “Is it allowed to verify the authenticity of the UI when the product is not in physical possession?” is answered with “Yes, but only as an additional check to Article 20 of Commission Delegated Regulation (EU) 2016/161.”


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07.07.2022 | NEWS

EC: Common Specifications for Certain High-Risk IVDs

EC: Common Specifications for Certain High-Risk IVDs

On 4 July 2022 the European Commission published the Implementing Regulation (EU) 2022/1107 to establish common specifications for certain class D in vitro diagnostic medical devices considered to be high-risk. These relevant harmonised standards had already been partially introduced in the repealed Directive 98/97/EC. Now the specifications have been updated and adapted to the state of the art.


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01.07.2022 | NEWS

ICMRA: Regulatory Collaboration Pilots

ICMRA: Regulatory Collaboration Pilots

The International Coalition of Medicines Regulatory Authorities (ICMRA) is announcing the initiation of two regulatory collaboration pilots addressing facility inspections and Chemistry and Manufacturing Controls (CMC) and Post-Approval Change (PAC) submission assessments and related regulatory actions.


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01.07.2022 | NEWS

FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs

FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs

The FDA issued a draft guidance outlining a framework of methods, designs and controls for preventing cross-contamination of non-penicillin beta-lactam antibacterial drugs and compounds, which serves as an update for a 2013 guidance with the same title. (Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability).


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10.06.2022 | NEWS

PIC/S: What’s planned in terms of GMP?

PIC/S: What’s planned in terms of GMP?

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has published its 2022 work plan with the organization’s planned actions for this year. Not only does PIC/S plan to resume its assessments for membership application but also to revise or draft new GMP guidelines.


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03.06.2022 | NEWS

EMA: Updated Q&A on Nitrosamines and Step 2-Template

EMA: Updated Q&A on Nitrosamines and Step 2-Template

 

The European Medicines Agency (EMA) has published a revised version 9 of its Q&A on nitrosamines for marketing authorisation holders dated 20 May 2022.


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03.06.2022 | NEWS

Swissmedic: Standalone Regulations for In vitro Diagnostic Medical Devices

Swissmedic: Standalone Regulations for In vitro Diagnostic Medical Devices

Concurrent with the application of the IVDR in the EU, the new Swiss regulation on in vitro diagnostic medical devices, IvDO, came into force on 26 May 2022. This is the first time since 2001 that the "third country rules" apply to IVDs in Switzerland, as they already do for all other medical devices for a year now (we reported). As of the same date, clinical trials with in vitro diagnostic medical devices are regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).


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27.05.2022 | NEWS

EMA: Final Guideline on Quality of Herbal Products

EMA: Final Guideline on Quality of Herbal Products

On 12 May 2022, the EMA published the final guideline on quality of herbal medicinal products/traditional herbal medicinal products. The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA) originally started working on the revision of the guideline in 2015. Revision 3 which now represents the final guidance was adopted in January 2022.


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27.05.2022 | NEWS

EC: IVDR for In-vitro-Diagnostic Medical Devices Entered into Force

EC: IVDR for In-vitro-Diagnostic Medical Devices Entered into Force

After a one-year postponement period, the European In Vitro Diagnostic Medical Devices Regulation (IVDR) finally came into force on 26 May 2022 and follows the Medical Device Regulation (MDR), which has been in force for one year.


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20.05.2022 | NEWS

FDA: Revised Guideline on OOS Results

FDA: Revised Guideline on OOS Results

The US FDA has revised its 16-year-old guidance on how to investigate out-of-specification (OOS) test results in laboratories. The document includes all necessary steps to be taken when investigating OOS test results. It also considers the responsibilities of the analyst and the laboratory supervisor in case of OOS results being identified, along with additional testing steps and a final evaluation of all results.


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20.05.2022 | NEWS

ICH: Final Q3D (R2) Guideline on Elemental Impurities

ICH: Final Q3D (R2) Guideline on Elemental Impurities

ICH Q3D (R2) has reached Step 4 of the ICH-Process and will now be distributed to the Member States for implementation. The revision (R2) focused on

  • the establishment of limits for elemental impurities by the dermal route of exposure, summarized in a new Appendix 5 Limits for Elemental Impurities by the Cutaneous and Transcutaneous Route
  • and error corrections of the PDEs for Silver (oral), Gold (oral, parenteral and inhalation) and Nickel (inhalation).

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17.05.2022 | NEWS

EMA: Public Consultation on Remote Batch Certification

EMA: Public Consultation on Remote Batch Certification

The EMA has published a four-page consultation document in the form of Q&As concerning the physical attendance and the place of a personal residence of a Qualified Person on 11 May 2022. The guidance states that the work of a QP must be adapted to current standards to enable remote certifications without a QP being present at the site. A public consultation is possible until 13 June 2022.


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13.05.2022 | NEWS

MDCG: Guidance on transitional provision of IVDR

MDCG: Guidance on transitional provision of IVDR

On 26 May 2022, the European IVD Regulation (EU) 2017/746 (In vitro Device Regulation) will enter into force. This will be accompanied by various transitional periods and requirements, which have been summarised and explained by the MDCG (Medical Device Coordination Group) in a new guidance document. The 17-page Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR is aimed at manufacturers who have so far complied with the requirements of Directive 98/79/EC and may continue to market their in vitro diagnostic devices in accordance with this Directive during the transitional periods.


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13.05.2022 | NEWS

EMA: Updating of Good Clinical Practice Annexes

EMA: Updating of Good Clinical Practice Annexes

The European Medicines Agency (EMA) has updated the annexes for the conduct of GCP inspections. First published in 2007, the annexes compile a number of seven documents.


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06.05.2022 | NEWS

PMDA: English version of the global principles for clinical trials revised

PMDA: English version of the global principles for clinical trials revised

Japan's PMDA (Pharmaceuticals and Medical Devices Agency) published changes to its principles for global clinical trials late last year. This revised document was published in English at the end of April 2022.


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06.05.2022 | NEWS

EMA: Updated Q&A on Parallel Distribution

EMA: Updated Q&A on Parallel Distribution

Centrally authorised medicinal products placed on the market in one European Member State may be marketed under the same name in any other Member State by a distributor independent of the marketing authorisation holder. This process of parallel distribution is supervised by the EMA.


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03.05.2022 | NEWS

EMA: Comments on the current ICH guideline Q9 (R1) quality risk management

EMA: Comments on the current ICH guideline Q9 (R1) quality risk management

The EMA has released the comments of the ICH guideline Q9 (R1) draft from december 2021 in late april. The document contributes principles and examples of tools for quality risk management. The document consists of 56 pages of comments from organizations such as the PDA, EFPIA and many others. In the following some excerpts:


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22.04.2022 | NEWS

GMP/GDP IWG Annual Report 2021

GMP/GDP IWG Annual Report 2021

On 19 April 2022, the EMA published the annual report of the GMP/GDP Inspectors Working Group for the year 2021. Both, Brexit and the COVID pandemic had resulted in no reports being issued for the last three years. Instead the EMA had published a Business Continuity Plan (BCP), which was primarily based on a prioritisation of tasks.


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14.04.2022 | NEWS

FDA asks for feedback on streamlined "Quality-Metrics" program

FDA asks for feedback on streamlined "Quality-Metrics" program

The US Food and Drug Administration (FDA) presented a "scaled-down" plan for collecting quality metrics from drug manufacturers end of March. The docket is an attempt to reactivate previously paused efforts to collect manufacturing quality metrics data. The primary aim of the program is to mitigate potential drug shortages and promote improved quality management in the pharmaceutical industry.


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14.04.2022 | NEWS

Japanese Pharmacopeia with English Translation

Japanese Pharmacopeia with English Translation

The Japanese MHLW (Japanese Minister of Health, Labour and Welfare) has released the 18th Edition of the Japanese Pharmacopoeia (JP) as an English translation for download free of charge.


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11.04.2022 | NEWS

TGA: Medicinal cannabis quality rules updated

TGA: Medicinal cannabis quality rules updated

The Australian regulatory authority for therapeutic goods TGA has updated its 19-pages quality requirements for medical cannabis products. These are now in line with TGO 93 and refer to

  • any medicinal cannabis product imported into or supplied in Australia
  • cannabis plant used in the manufacture of medicinal cannabis products e.g., as an ingredient or as a starting material for an extract used as an ingredient
  • any other ingredients used in the manufacture of medicinal cannabis products, such as excipients
  • steps and procedures carried out in the manufacture of medicinal cannabis product.

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11.04.2022 | NEWS

MDCG: IVDR-implementation and preparedness plan

MDCG: IVDR-implementation and preparedness plan

The Medical Device Coordination Group MDCG, a group of Member States experts, endorsed a joint implementation plan on the implementation of the IVDR, more precisely Regulation (EU) 2017/746 on invitro diagnostic medical devices. The plan should serve to set priority actions and monitor their implementation.  The IVDR will enter into force on 26 May 2022 with an extended transitional period of five years.


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01.04.2022 | NEWS

ICH: Draft Guidelines ICH Q14 und Q2(R2) published

ICH: Draft Guidelines ICH Q14 und Q2(R2) published

The draft ICH Q14 guideline on analytical procedure development reached stage 2 of the ICH process on 24 March 2022. This also applies to the revised ICH Q2 (R2) guideline on the validation of analytical procedures. Both documents are now in the public consultation phase. They jointly describe the development and validation activities that should be applied during the life cycle of an analytical procedure to assess the quality of medicinal substances and products.


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18.03.2022 | NEWS

Update on Publication Date of EU Annex 1 at the ISPE Conference.

Update on Publication Date of EU Annex 1 at the ISPE Conference.

On 14/15 March 2022, the ISPE Aseptic Conference took place in North Bethesda, USA. The hybrid conference opened with a keynote presentations on regulatory news.

Paul A. Gustafson, who is chairing the PIC/S this year, gave an overview on the PIC/S activities and in this context referred to the future Annex 1 of the EU GMP Guide: The document is in its final adoption process. A publication is to be expected between the beginning of July and the end of September this year. The European Commission is currently awaiting the review of the PIC/S and the WHO. Both organisations had contributed to the two draft documents of Annex 1. The European Commission has not revealed a release date, yet.


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11.03.2022 | NEWS

Swissmedic: Validity of GMP certificates during COVID

Swissmedic: Validity of GMP certificates during COVID

Swissmedic announces the following regarding the validity of GMP certificates:

"The GMP certificates issued by Swissmedic list the date of the underlying inspection. They do not contain a validity date. However, following the practice for GMP certificates in the EU database EudraGMDP, it is often assumed by companies or other authorities that GMP certificates based on an inspection more than 3 years ago lose their informative value about the compliance status and therefore lose their validity."


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11.03.2022 | NEWS

EMA: Concept Paper on Agriculture of Herbal Drugs, GMP versus GACP

EMA: Concept Paper on Agriculture of Herbal Drugs, GMP versus GACP

The HPMC (Committee on Herbal Medicinal Products, HPMC) of the EMA has published a concept paper on Good agricultural and collection practice for starting materials of herbal origin on 1 March 2022. Of interest to GMP professionales is, that the revision of the original guideline dating back to 2006, will address open questions about the applicability of GACP versus GMP, or a requirement of a combination of both. With a growing market for herbal medicinal product, e.g., Cannabis products, enhanced guidelines on the subject intent to clarify open issues.


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04.03.2022 | NEWS

IPEC: Position Paper on Nitrosamine Risks in Excipients

IPEC: Position Paper on Nitrosamine Risks in Excipients

The IPEC (International Pharmaceutical Excipients Council Federation) has published a summarizing position paper on „The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products. The 7-page paper describes the IPEC Federation’s position on the role of excipients when conducting N-nitrosamine risk assessments for medicinal products.


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25.02.2022 | NEWS

FDA: Proposal to align ISO 13485 with 21 CFR Parts 4 and 820

FDA: Proposal to align ISO 13485 with 21 CFR Parts 4 and 820

The US FDA is proposing to amend the cGMP requirements of the Quality System Regulation for medical devices, namely the 21 CFR Parts 4 and 820. Finally, the ISO 13485:2016 should be incorporated in the US Quality System, by reference. This proposal comes four years after the US FDA announced its willingness to align the two systems.


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22.02.2022 | NEWS

EC: Final Annex 21 on Importation of Medicinal Products

EC: Final Annex 21 on Importation of Medicinal Products

The EU GMP Annex 21: Importation of medicinal products has finally been published on February 21, 2022, and will enter into force on August 21, 2022. The 6-page new Annex summarises the GMP requirements for Manufacturing Import Authorization (MIA) holders of human, investigational, and veterinary medicinal products from outside the EU/EEA. Medicinal products entering the EU/EEA for export only and are neither processed in any way nor released for placing on the EU/EEA market, are not covered by this Annex.


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18.02.2022 | NEWS

FDA: CDER Guidance Agenda for 2022

FDA: CDER Guidance Agenda for 2022

CDER released its Guidance Agenda for the year 2022. The list includes all guidances planned to be developed or finalised this year. The agenda should be seen as an indicator for the topics CDER is advancing to tackle but is not binding for the Center.


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18.02.2022 | NEWS

FDA: Robert Califf confirmed as FDA’s Commissioner in narrow vote

FDA: Robert Califf confirmed as FDA’s Commissioner in narrow vote

Robert M. Califf, M.D., was sworn in as new Commissioner of the Food and Drugs Administration on February 17, 2022. He has previously served as Commissioner from February 2016 to January 2017, during President Obama’s final year in office. 


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11.02.2022 | NEWS

EMA: Q&A on nitrosamines revised on risk of multiple impurities

EMA: Q&A on nitrosamines revised on risk of multiple impurities

The European Medicines Agency (EMA) issued a revised Version 7 of its Q&A guidance on nitrosamines dated January 22, 2022. The revision includes a new nitrosamine for testing and an updated section on testing and control of multiple impurities in one product. For such a case, a step-by-step decision tree is presented in Annex 1.


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07.02.2022 | NEWS

EC: Regulation (EU) 2019/6 and GDP-regulations on veterinary medicinal products in force

EC: Regulation (EU) 2019/6 and GDP-regulations on veterinary medicinal products in force

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) entered into force on 28 January 2022.  It modernises the existing rules on the authorisation and use of veterinary medicines in the European Union (EU). 


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04.02.2022 | NEWS

EU: EU Clinical Trials Regulation and new Information System finally in place

EU: EU Clinical Trials Regulation and new Information System finally in place

As of 31 January 2022, the new Clinical Trials Regulation (EU) No. 536/2014 (CTR) entered into force, repealing the Clinical Trial Directive (EC) No. 2001/20/EC. This step is meant to facilitate the daily business of sponsors in the EU immensely, when it comes to filing clinical trial applications. The new Clinical Trials Information System (CTIS) serves as a single-entry point for submission and assessment of clinical trial data for all EU and EEA countries and has gone live.


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04.02.2022 | NEWS

PIC/S: Revision of GMP Guide Annex 13 and new Annex 16

PIC/S: Revision of GMP Guide Annex 13 and new Annex 16

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised its PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products to include

  • the revised Annex 13 on the Manufacture of Investigational Medicinal Products and
  • the new Annex 16 on the Certification by the Authorised Person and Batch Release.

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28.01.2022 | NEWS

EMA: Paper on GMP Responsibilities and MAHs in Version 2

EMA: Paper on GMP Responsibilities and MAHs in Version 2

The EMA released Version 2 of its Reflection paper on GMP and Marketing Authorisation Holders on 10 January 2022. A minor text addition to the document was performed: The section on „Serialisation Data - Uploading Responsibilities" was amended with the following paragraph regarding Contract Manufacturing Organisations:


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21.01.2022 | NEWS

FDA: Hold on Inspections

FDA: Hold on Inspections

The US FDA announces that the spread of the Omicron variant will lead to further delays in resuming inspection activities. Originally, this step was planned for February 2022. The date is now being pushed further back. With the current developments of the Covid 19 pandemic, no new resumption date has been communicated.  


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14.01.2022 | NEWS

Amendment of Delegated Regulation (EU) on Safety Features

Amendment of Delegated Regulation (EU) on Safety Features

Already in March last year, an adaption of the Delegated Regulation (EU) 2016/161 on safety features allowed a temporary derogation of the obligation for wholesalers to deactivate the individual identifier (IE) of medicinal products exported to the UK - as a third country (we reported). This exemption was granted for the year 2021.


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07.01.2022 | NEWS

EC: Updated Q&A on Safety Features, Version 19

EC: Updated Q&A on Safety Features, Version 19

The European Commission published Version 19 of the Q&A on safety features for medicinal products in late December 2021.

What's new?

  • Question 1.29: Do the unique identifiers of reference and retention samples taken from stock in compliance with Annex 19 of the EU GMP Guidelines5 and uploaded to the EMVS have to be decommissioned? If yes, to what status?
    Answer: Yes, if a sample of a batch is taken as reference or retention sample after uploading in EMVS, it should be decommissioned as "sample". If a sample is taken voluntarily by a wholesaler that fall outside the scope of Annex 19, they should be decommissioned as "destroyed".

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21.12.2021 | NEWS

EMA: ICH Q9 on Quality Risk Management in Step 2b

EMA: ICH Q9 on Quality Risk Management in Step 2b

On 16 December 2021, EMA published the ICH Q9 draft document on Quality Risk Management (QRM) in step 2b. The draft provides important additional guidance on four specific areas:

  • the levels of subjectivity in risk assessments and in QRM outputs,
  • the product availability risks,
  • the lack of understanding as to what constitutes formality in QRM work, and
  • the lack of clarity on risk-based decision-making.

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17.12.2021 | NEWS

ICMRA: Authorities summarise global experiences on remote inspections

ICMRA: Authorities summarise global experiences on remote inspections

The International Coalition of Medicines Regulatory Authorities, ICMRA, has published a comprehensive reflection paper on experiences with different inspection models to maintain GCP and GMP inspections during the covid pandemic. The working group responsible for the paper was composed of representatives from various regulatory agencies around the world. To anticipate the group's conclusion: Remote inspections enable minimal regulatory oversight during the pandemic but will not be able to replace on-site inspections in the future.


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14.12.2021 | NEWS

TGA: Hybrid and remote GMP-inspections

TGA: Hybrid and remote GMP-inspections

The Australian authority TGA has published a revision of the guideline on licenses and certification "Guidance on Australian manufacturing licenses and overseas good manufacturing practice (GMP) certification" on 1 December 2021. The revision relates to an expansion of possible inspection types as well as the scheduling of the inspection for licensing procedures.


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10.12.2021 | NEWS

EMA: Overview on comments on drug device guidance

EMA: Overview on comments on drug device guidance

On 6 December 2021, the EMA published all stakeholder comments received on the Guideline on quality documentation for medicinal products when used with a medical device (we reported). It will enter into force on 1 January 2022. Comments were received from 36 different stakeholders from all over Europe, including e.g., MedTech Europe, Medicines for Europe or the Parenteral Drug Association, PDA.


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07.12.2021 | NEWS

Swissmedic: Registration required for medical product manufacturers

Swissmedic: Registration required for medical product manufacturers

To ensure market surveillance of medical devices, manufacturers, authorized representatives and importers based in Switzerland must register with Swissmedic within three months of first placing a product on the market. This was revealed in a Swissmedic announcement in late November.
After the applicants have undergone the process, they will be assigned an individual Swiss identification number, the Swiss Single Registration Number (CHRN).


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03.12.2021 | NEWS

EU: Implementing regulation on EUDAMED published

EU: Implementing regulation on EUDAMED published

On 26 November 2021, the European Commission issued the Implementing Regulation (EU) 2021/2078 on the European Database for Medical Devices, Eudamed. The document provides a legally binding framework for all users.


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03.12.2021 | NEWS

USP: New General Chapter <1469> on Nitrosamine Impurities

USP: New General Chapter <1469> on Nitrosamine Impurities

As of 2 December 2021, the new general chapter <1469> on nitrosamine impurities has been added to the United States Pharmacopeia (USP). With this, it is intended to support both pharmaceutical manufacturers and authorities in assessing the presence of nitrosamines and implementing appropriate control strategies and analytical procedures. The chapter is aligned with the current FDA guidances.


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26.11.2021 | NEWS

EMA: Revision of Q&A on pre-authorisation of centralised procedures

EMA: Revision of Q&A on pre-authorisation of centralised procedures

The European Medicines Agency has revised its 142-page document European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. The publication of 22 November 2021 includes the adjustments already made in October, as well as an update to paragraph 2.9 on the procedural structure of application from November. All changes to the document are marked with a corresponding date reference and concern section 2 "Steps prior to submitting the application".


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19.11.2021 | NEWS

EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines

EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines

The European Medicines Agency (EMA) has published a 13-page Q&A including 87 questions and answers from a webinar held on the topic of integrating EudraGMDP and OMS (Organisation Management Services) into the new regulatory framework for veterinary medicines.


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19.11.2021 | NEWS

FDA: President Biden nominates Dr. Robert Califf for FDA commissioner

FDA: President Biden nominates Dr. Robert Califf for FDA commissioner

Finally, the long-awaited nomination for the next FDA commissioner is here. President Biden has nominated Dr. Robert Califf, a clinical trial expert and founding director of the Duke Clinical Research Institute.


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19.11.2021 | NEWS

EU GMP Guide: New concept papers for revision of Annex 4 and Annex 5 for VMPs

EU GMP Guide: New concept papers for revision of Annex 4 and Annex 5 for VMPs

The European Medicines Agency has published two new concept papers for Annex 4 and Annex 5 for veterinary medicinal products on 11 November 2021:

  • Concept paper on the revision of annex 4 of the guidelines on good manufacturing practice – manufacture of veterinary medicinal products other than immunologicals
  • Concept paper on the revision of annex 5 of the guidelines on good manufacturing practice for medicinal products – manufacture of immunological veterinary medicinal products

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12.11.2021 | NEWS

EC: Mandate for strategic approach on pharmaceuticals and environment

EC: Mandate for strategic approach on pharmaceuticals and environment

The European Commission has tasked its ad-hoc working group (WG) on pharmaceuticals in the environment with drafting a concept paper on the regulatory framework. The WG formed in 2020, is joined by the following Member States: Austria, The Czech Republic, Finland, France, Germany, Ireland, The Netherlands, Slovenia, Spain, Sweden, Poland, Romania, Italy and the European Medicines Agency (EMA).


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12.11.2021 | NEWS

TGA continues use of remote inspections

TGA continues use of remote inspections

The Australian Therapeutic Goods Administration, TGA,  updated its GMP approach to overseas manufacturers of medicines and biologicals on 1 November 2021. With the COVID-pandemic still being an issue, TGA named remote inspections the only currently available option for certification applications.


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05.11.2021 | NEWS

EU: Procedures on Inspections and Exchange of Information in new Version 18

EU: Procedures on Inspections and Exchange of Information in new Version 18

The European Commission has revised and restructured the Compilation of Community Procedures on Inspections and Exchange of Information. In addition to new content and editorial adjustments, the 295-page document has been divided into a Part I including procedural topics and a Part II containing interpretation documents and templates. The documents were last updated in 2014.


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29.10.2021 | NEWS

FDA/CDRH: Proposed Guidances for FY 2022

FDA/CDRH: Proposed Guidances for FY 2022

The FDA’s Center for Devices and Radiological Health (CDRH) has published its lists with guidance documents intended to be published next year. At this stage CDRH is interested in receiving external feedback on whether the listed documents should be revised or withdrawn.


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29.10.2021 | NEWS

US, Canada, and UK issue joint principles on Good Machine Learning Practice

US, Canada, and UK issue joint principles on Good Machine Learning Practice

The US FDA, Health Canada, and the British regulatory agency MHRA have jointly released 10 guiding principles to support the development of Good Machine Learning Practice (GMLP). As a basic framework it should help to promote safe, effective, and high-quality medical devices, while using AI (artificial intelligence) and ML (machine learning).


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22.10.2021 | NEWS

FDA: Inspectional Observations 2021 published

FDA: Inspectional Observations 2021 published

The FDA’s Office of Regulatory Affairs (ORA), responsible for inspections and other field activities, has released its summary on inspectional observations listed on FDA Forms 483 from October 2020 to September 2021.


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15.10.2021 | NEWS

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

USP: General Chapter 1220 of Analytical Procedure Life Cycle pre-published

The United States Pharmacopeia has released a new Chapter 1220 on “Analytical Procedure Life Cycle” prior to its official publication and entering into force on 1 May 2022. The chapter considers the validation activities that take place across the entire life cycle of an analytical procedure and provides a framework for the implementation of the life cycle approach.


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15.10.2021 | NEWS

EC: Proposal for progressive introduction of IVDR

EC: Proposal for progressive introduction of IVDR

On 14 October 2021, the European Commission has proposed a “progressive roll-out” of the upcoming In Vitro Diagnostic Medical Devices Regulation, IVDR. The reason given for that is to prevent disruption in the supply of those essential healthcare products that fall under it, as well as a serious shortage of notified body capacity. The IVDR was planned to apply as of 26 May 2022.


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12.10.2021 | NEWS

EMA: Q&A on Nitrosamines updated

EMA: Q&A on Nitrosamines updated

The European Medicines Agency EMA has further updated its Q&A on nitrosamine impurities. The document is intended to support marketing authorization holders of human medicinal products and considers the latest regulatory requirements (we reported).


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08.10.2021 | NEWS

PIC/S: China applies for PIC/S accession

PIC/S: China applies for PIC/S accession

The Chinese NMPA applied for PIC/S pre-accession on 24 September 2021. Although this stage is a voluntary assessment process, gaps are identified between PIC/S membership requirements and the system used by the regulatory agency that is interested.


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01.10.2021 | NEWS

EDQM: Mutagenic azido impurities in Losartan

EDQM: Mutagenic azido impurities in Losartan

The European Directorate for the Quality of Medicines, EDQM, has identified another azido impurity which was tested positive in a mutagenic evaluation. So far, it has only been found in "Losartan potassium".


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01.10.2021 | NEWS

EMA: Validity of GMP and GDP certificates extended

EMA: Validity of GMP and GDP certificates extended

The European medicines regulatory network has announced the automatically applied extension of the validity of GMP and GDP certificates for sites in the EEA (European Economic Area) until the end of 2022, unless there are restrictions on the validity period stated in the clarifying remarks of the certificate. This extension also applies to time-limited manufacturing and import and wholesale authorisations.


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29.09.2021 | NEWS

EUDRAGMDP: EMA with important information for all users

EUDRAGMDP: EMA with important information for all users

As communicated by the EMA, the EUDRAGMDP database will be „merged“ with EMA’s Organisation Management Service (OMS). This is an important change to be aware of for all manufacturers, importers and distributors of human and veterinary medicines whose information is recorded in EUDRAGMDP.


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27.09.2021 | NEWS

FDA: Revised Q&A on Biosimilar Development

FDA: Revised Q&A on Biosimilar Development

On 17 September 2021, the US FDA released the revised Q&A Guidance on Biosimilar Development and the BPCI Act. The 28-page document provides rapid, development-related guidance to biosimilar and interchangeable biosimilar sponsors and other stakeholders on discrete issues.


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27.09.2021 | NEWS

EU: Amendment to Delegated Regulation (EU) 2016/161 on safety features

EU: Amendment to Delegated Regulation (EU) 2016/161 on safety features

On 21 September 2021, an amendment to Delegated Regulation (EU) 2016/161 was published in the Official Journal of the European Union. Article 47 "Evaluation of notifications" was adapted and in Annex I, containing the list of medicinal products exempted from the obligation to bear the safety features, a new entry has been added.


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20.09.2021 | NEWS

Final draft of new USP chapter <1083> Supplier Qualification

Final draft of new USP chapter <1083> Supplier Qualification

On September 15, the U.S. Pharmacopeia USP published the final draft of the chapter <1083> Supplier Qualification.


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08.09.2021 | NEWS

EDQM: New chapter on balances in the European Pharmacopoeia

EDQM: New chapter on balances in the European Pharmacopoeia

As of July 2021, the European Pharmacopoeia (Ph. Eur.) now contains chapter 2.1.7 "Balances for analytical purposes". It was included as an addition to section 2.1 Apparatus and defines the requirements placed on the "balance" tool in an analytical procedure.


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06.09.2021 | NEWS

EDQM: Guidance for electronic submissions of CEP applications revised

EDQM: Guidance for electronic submissions of CEP applications revised

In July 2021, EDQM published a revised version of the document "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" (PA/PHCEP (09) 108). This guidance includes the current requirements for how an application for Certificates of Suitability must be conducted in eCTD format.


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26.08.2021 | NEWS

MDCG: Guidance on repackaging and relabeling processes of devices

MDCG: Guidance on repackaging and relabeling processes of devices

This month, the Medical Devices Coordinating Group of the European Commission, MDCG, published a 7-page guideline for notified bodies, distributors, and importers of medical devices. It should provide a basis for the certification of quality management systems (QMS) related to repackaging and relabeling processes of medical devices according to MDR and IVDR.


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25.08.2021 | NEWS

WHO publishes draft documents on medicinal gases, IPs and development facilities

WHO publishes draft documents on medicinal gases, IPs and development facilities

The WHO has published three GMP-relevant draft documents in recent weeks:

  • WHO good manufacturing practices for investigational products
  • WHO good manufacturing practices for medicinal gases, Rev.1
  • WHO good practices for research and development facilities of pharmaceutical products

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20.08.2021 | NEWS

EMA: Draft Guidance on SmPC for ATMPs with Gene-modified Cells

EMA: Draft Guidance on SmPC for ATMPs with Gene-modified Cells

The European Medicines Agency (EMA) has issued a 31-page draft guideline describing the information to be included in the Summary of Product Characteristics (SmPC), labelling and package leaflet for Advanced Therapy Medicinal Products (ATMPs) that contain genetically modified cells.


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20.08.2021 | NEWS

EMA: Guideline on quality documentation for combination products

EMA: Guideline on quality documentation for combination products

Following a two-years drafting process the CHMP of the EMA has adopted the final guideline on quality documentation for medicinal products when used with a medical device on July 22, 2021.


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06.08.2021 | NEWS

EMA: Paper on GMP Responsibilities and MAHs

EMA: Paper on GMP Responsibilities and MAHs

On 23 July 2021, EMA has finalized its reflection paper on GMP-related responsibilities and marketing authorisation holder companies (MAHs). As various tasks are spread over different chapters and annexes of the EU GMP Guide and various directives, the paper now summarizes them in a single 29-page document. This is to provide clarity on which responsibilities are to be considered and what they signify for MAHs at a practical level.


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30.07.2021 | NEWS

ICH: ICH-Q13 Draft on Continuous Manufacturing released

ICH: ICH-Q13 Draft on Continuous Manufacturing released

On 27 July 2021, ICH published the anticipated draft of its Q13 Guideline on Continuous Manufacturing of Drug Substances & Drug Products. In Stage 2 of the ICH process the 44-page document has thus been released for public commentation.

The guideline is intended to provide "scientific and legal considerations for the design, implementation, operation and lifecycle management of continuous manufacturing (CM)".


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23.07.2021 | NEWS

FDA: Push for more authority on device shortages

FDA: Push for more authority on device shortages

As part of the annual budget planning acting FDA Commissioner Janet Woodcock has addressed the problem of weaknesses in the medical devices supply chain and its overall dependence on foreign medical devices.


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20.07.2021 | NEWS

PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19

PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19

PIC/S published a new guidance COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) which entered into force on 15 July 2021.

The guidance is addressed to inspectors and covers the actions to be taken during the planning phase of an inspection, in consultation with the site to be inspected.


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20.07.2021 | NEWS

PIC/S: Final Recommentation Document on Risk-Based Change Management

PIC/S: Final Recommentation Document on Risk-Based Change Management

On 15 July 2021 the PIC/S recommendation document How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management (PI 054-1) came into force. The document provides practical guidance and covers all relevant steps in change management process – change proposal, change assessment, change planning and implementation, change review and effectiveness checks.


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16.07.2021 | NEWS

EC: Kiwa Cermet Italia S.P.A. becomes 21st Notified Body

EC: Kiwa Cermet Italia S.P.A. becomes 21st Notified Body

The European Commission announced on 14 July 2021, that the Italian company Kiwa Cermet Italia S.P.A. has been appointed as the 21st Notified Body under the EU Medical Devices Regulation (MDR) 2017/745. It has been assigned the number 0476 in the EC's Nando database.


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09.07.2021 | NEWS

PIC/S: Final guideline on Data Management and Integrity

PIC/S: Final guideline on Data Management and Integrity

After five years of drafting, PIC/S has now published the final version of a new guideline on data integrity, the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1). The document has already been applied in practice on a trial basis during this time and has been modified twice.


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09.07.2021 | NEWS

EMA: Updated Q&A on Drug-Device-Combination Products under new MDR/IVDR

EMA: Updated Q&A on Drug-Device-Combination Products under new MDR/IVDR

EMA has updated its Q&A document on drug-device combination products by end of June 2021. It includes the current requirements under the Medical Devices Regulation (MDR), which entered into force on 26 May 2021. Marketing authorisation holders of combination products are provided with detailed information on all current adjustments.


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08.07.2021 | NEWS

EMA: Revised Q&A on assessment of nitrosamine impurities

EMA: Revised Q&A on assessment of nitrosamine impurities

On 2 July 2021 the European Medicines Agency has released a revised version of the 17-pages Q&A to aid marketing authorisation holders to assess their risk for nitrosamine impurities. The revision affects questions 3 and 10:

  • For the ‘call for review’ for chemically synthesised and biological medicinal products, when and how should MAHs report steps 1 and 2 to competent authorities? (Q&A 3)

  • Which limits apply for nitrosamines in medicinal products? (Q&A 10).


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05.07.2021 | NEWS

Swissmedic: Information sheet on the Swiss Authorised Representative (CH-REP) for medical devices

Swissmedic: Information sheet on the Swiss Authorised Representative (CH-REP) for medical devices

The aborted negotiations between Switzerland and the EU on the institutional framework agreement (we reported) are casting their shadow: new regulations are needed to ensure the safe supply of medical devices within Switzerland. However, not only Swiss manufacturers are affected. Medical device manufacturers who are not domiciled in Switzerland but who place products on the market there must also mandate an authorized representative in Switzerland.


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02.07.2021 | NEWS

IVDR: Netherlands' DEKRA designated fifth Notified Body

IVDR: Netherlands' DEKRA designated fifth Notified Body

The Netherlands’ DEKRA Certification B.V. was named the fifth notified body under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in June 2021. Dekra Certification B.V. is also a designated notified body under the MDR.


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02.07.2021 | NEWS

EC:Updated Version 18B of Q&A on Safety Features

EC:Updated Version 18B of Q&A on Safety Features

The European Commission published version 18B of the Q&A on safety features for medicinal products in late May 2021. In the 34-page document, question 1.14 "Are there mandatory specifications for tamper evidence?" was updated.


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24.06.2021 | NEWS

PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S has started the consultation process for the adoption of Annex 16 of the EU GMP Guide. It is a very important step towards international harmonisation of GMP requirements.


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18.06.2021 | NEWS

EMA: Annual Report 2020 published

EMA: Annual Report 2020 published

As every year, the EMA now publishes its report for 2020, in which it outlines achievements, decisions and objectives of the year.


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18.06.2021 | NEWS

FDA presents first global forum for generics

FDA presents first global forum for generics

In early June, the FDA unveiled the Generic Drug Cluster, the first forum for leading regulatory authorities to address the global development of generic drugs.


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11.06.2021 | NEWS

Operation PANGEA XIV: Worldwide week of action against criminal online trade in medicines

Operation PANGEA XIV: Worldwide week of action against criminal online trade in medicines

Once a year, operation PANGEA takes place, a globally organized action by Interpol against the online distribution of illegally imported medicines. Within this week of action, participating countries check (and close) suspicious websites and seize counterfeit medicines. In addition, this action aims to create public awareness of the issue.


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10.06.2021 | NEWS

EMA: Updated guidance documents on parallel distribution

EMA: Updated guidance documents on parallel distribution

The European Medicines Agency, EMA, has updated its regulatory and procedural guidance documents on parallel distribution as of 9 June 2021. 


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07.06.2021 | NEWS

CDRH (FDA): Medical devices from Steril Milano may not be sufficiently sterilized - import ban for the U.S.

CDRH (FDA): Medical devices from Steril Milano may not be sufficiently sterilized - import ban for the U.S.

The two facilities of the Italian company Steril Milano S.r.L. in Monza and Reggiolo have closed their doors since March 2021. The company, which offers a sterilization service for medical devices, is facing serious allegations of manipulation. In the meantime, Steril Milano S.r.L's certificate has been withdrawn by the responsible accreditation body.


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04.06.2021 | NEWS

FDA: Two new guidelines on supply chain security

FDA: Two new guidelines on supply chain security

The FDA has finalized two guidance documents to help ensure that prescription drugs are identified and traced properly while moving through the supply chain. The documents address how to comply with the DSCSA (Drug Supply Chain Security Act) requirements.


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28.05.2021 | NEWS

EC: EU MDR in force along with Q&A

EC: EU MDR in force along with Q&A

Finally the date has come: as of 26 May 2021 the EU rules on medical devices (EU MDR) entered into force. Following a one year postponement due to COVID-19, this regulation is considered a big step forward to improve the safety and quality of medical devices. There are, however, still plenty of uncertainties for their manufacturers, but there is also a saying that every journey begins with single steps.


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28.05.2021 | NEWS

Switzerland, EU-MDR und a missing MRA

Switzerland, EU-MDR und a missing MRA

The new European medical device regulation came into force on 26 May 2021. Parallel, a complete revision of the Medical Devices Regulation MepV was carried out in Switzerland, under the responsibility of the Swiss BAG (Federal Office of Public Health). In context of the alignment of the MepV and the KlinV-Mep with the new EU regulations MDR and IVDR on medical devices, it was also necessary to update the existing MRA (Mutual Recognition Agreement) between Switzerland and the EU. This agreement ensures barrier-free market access and joint implementation. The MRA is, in turn, part of an "overall package" of an institutional framework agreement (Insta), which has not yet been conclusively agreed on. On the contrary: Switzerland has meanwhile broken off negotiations with the EU and described them as "having failed".


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25.05.2021 | NEWS

Swissmedic: First agreement on close cooperation with German Federal Office of Consumer Protection and Food Safety (BVL) for veterinary medicinal products

Swissmedic: First agreement on close cooperation with German Federal Office of Consumer Protection and Food Safety (BVL) for veterinary medicinal products

On 18 May 2021, Swissmedic and the Federal Office of Consumer Protection and Food Safety (BVL) signed a first Memorandum of Understanding on cooperation in the area of veterinary medicinal products.


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21.05.2021 | NEWS

FDA: Update on remote inspections guidance and future roadmap

FDA: Update on remote inspections guidance and future roadmap

On 17 May 2021 the USFDA has released a revised version of its Q&A guidance on remote inspections. The 14-page document was originally published in August 2020 (we reported). As the pandemic still restricts most onsite inspections the FDA further clarifies general questions that came up since then.


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21.05.2021 | NEWS

MHRA launches its own GMDP database

MHRA launches its own GMDP database

The British MHRA has set up a standalone MHRA-GMDP database as a new service (alpha release). This step obviously separates the UK from the EudraGMDP where the competent EU authorities publish manufacturing and wholesale approvals, GMP certificates and non-compliance reports.


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07.05.2021 | NEWS

ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs

ICH: ICH Q3C(R8) Guideline for Residual Solvents contains new PDEs

ICH published the revised version (Step 4) of the ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents on 22 April 2021.


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29.04.2021 | NEWS

PIC/S: Revision of the PIC/S GMP Guide PE 009-15

PIC/S: Revision of the PIC/S GMP Guide PE 009-15

As announced by PIC/S on 23 April, 2021, the PIC/S GMP Guide has been revised. The changes will take effect on 1 May 2021. 


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16.04.2021 | NEWS

FDA:New Guidance on remote interactive inspections

FDA:New Guidance on remote interactive inspections

On 14 April 2021 the US FDA has published a new guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency”. This in fact was long overdue.  It outlines 

  • how remote interactive evaluations will be requested by the FDA and 

  • how they will be conducted for the duration of the COVID-19 pandemic.


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16.04.2021 | NEWS

Swissmedic: Harmonization of requirements on nitrosamines with EU

Swissmedic: Harmonization of requirements on nitrosamines with EU

On 16 April 2021, Swissmedic announced that it is seeking harmonization with EU regulations regarding the handling of nitrosamine impurities.


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15.04.2021 | NEWS

FDA: Patrizia Cavazzoni, M.D., to lead CDER

FDA:  Patrizia Cavazzoni, M.D., to lead CDER

On 12 April 2021, Dr Janet Woodcock, acting head of the US FDA, announced Dr Patrizia Cavazzoni's new role as director of CDER.


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09.04.2021 | NEWS

Export to UK: Exemption for Wholesalers

Export to UK: Exemption for Wholesalers

The European Union has published the Delegated Regulation (EU) 2021/457 in its Official Journal on 17 March 2021. It amends the Delegated Regulation (VO) 2016/161 on safety features necessary for the packaging of medicinal products for human use. The amendment is to exempt the obligation for wholesalers to deactivate the unique identifier of medicinal products exported to the United Kingdom, being considered a third country now.


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26.03.2021 | NEWS

EMA: Q&A on the implementation of the Ireland/Northern Ireland Protocol

EMA: Q&A on the implementation of the Ireland/Northern Ireland Protocol

EMA published Revision 3 of the Q&A on the Protocol on Ireland and Northern Ireland on 5 March 2021. The 11-page document contains 28 pairs of questions and answers. It is updated regularly and will be of interest to all GMP professionals who have business relationships with companies in Northern Ireland.


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26.03.2021 | NEWS

EMA: PDE for chlorobutanol as excipient reviewed

EMA: PDE for chlorobutanol as excipient reviewed

The CMDh (EMA's Coordination Group for Mutual Recognition and Decentralized Procedures) has approached one of the EMA's Safety Working Parties (SWPs) with the following two questions regarding chlorobutanol:

  1. Can the Safety Working Party confirm that the levels of chlorobutanol commonly used in medicinal products are safe from a toxicological point of view?
  2. Is it possible to determine acceptable intake levels of chlorobutanol?

The EMA published the 15-page SWP response document to these questions on March 17, 2021.


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25.03.2021 | NEWS

MHRA to pick up on-site inspections by end of March

MHRA to pick up on-site inspections by end of March

The MHRA announces its return  to on-site risk based GxP inspections starting from 29 March 2021. However, it is planned to use a combined approach of both, remote and on-site inspections.


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18.03.2021 | NEWS

MDCG: Guidance on custom-made medical devices according to MDR

MDCG: Guidance on custom-made medical devices according to MDR

The Medical Device Coordination Group (MDCG) published an eight-page Q&A document titled Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices (MDCG 2021-3) on 15 March 2021.


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12.03.2021 | NEWS

MHRA and EU: Medicinal products in Northern Ireland

MHRA and EU: Medicinal products in Northern Ireland

The European Commission published a Notice this January dealing with the legal framework for medicinal products marketed in Northern Ireland. On 9 March 2021, the UK MHRA, for its part, followed up and also addressed the issue. 


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12.03.2021 | NEWS

Swissmedic: Data on imports of illegal medicinal products via the internet

Swissmedic: Data on imports of illegal medicinal products via the internet

On 4 March 2021, Swissmedic announced the numbers on medicinal products illegally imported into Switzerland. In 2020, 6733 illegal imports were recorded. Compared to the previous year, the number has decreased only slightly.  Among the countries of origin, Singapore has replaced India, which has long been in the lead. It was followed by Western European countries such as the UK and Germany in particular.

Singapore is increasingly being used as a hub by suppliers of illegal medicinal products.


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10.03.2021 | NEWS

WHO/IAEA: Draft Guidance on GMP for Investigational Radiopharmaceutical Products

WHO/IAEA: Draft Guidance on GMP for Investigational Radiopharmaceutical Products

WHO published a 31-page draft guideline, "GMP for investigational radiopharmaceutical products", in March 2021. It offers recommendations for minimum standards in the manufacture of new radiopharmaceuticals for Phase I-III clinical trials that do not have a marketing authorization (MAA).


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05.03.2021 | NEWS

EDQM: Revision of Certification of Suitability for a Sartan monograph

EDQM: Revision of Certification of Suitability for a Sartan monograph

As reported earlier, the European Pharmacopoeia Commission implemented five new sartan monographs in a rapid procedure at the end of February. They are scheduled to become effective already on 1 April 2021. For holders of a Certification of Suitability (CEP), this may, but does not necessarily, mean adjusting their control strategies for nitrosamine impurities. EDQM has now published supplemental information on this topic:


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26.02.2021 | NEWS

EDQM: Five Pharmacopoeia monographs on Nitrosamine contamination in Sartans revised and implemented immediately

EDQM: Five Pharmacopoeia monographs on Nitrosamine contamination in Sartans revised and implemented immediately

On 23 February 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced that five monographs on sartans have been revised. They will be effective immediately as of 1 April 2021. 


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26.02.2021 | NEWS

EMA: Update on recommendations for handling nitrosamines

EMA: Update on recommendations for handling nitrosamines

On 22 February 2021, the European Medicines Agency (EMA) published a 14-page implementation plan dealing with the prevention of nitrosamine impurities. It is based on the results of the CHMP's scientific review of the subject.   


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25.02.2021 | NEWS

Swissmedic: Permanent participation in "Orbis"

Swissmedic: Permanent participation in "Orbis"

On 17 February 2021, Swissmedic announced that it will now permanently support the "Orbis" project. Orbis enables manufacturers to submit their marketing authorization applications submitted to the US FDA simultaneously to other international regulatory authorities, provided they participate in the project.


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25.02.2021 | NEWS

FDA: Revision of Nitrosamine Guidance and extension of timeframe for risk assessments

FDA: Revision of Nitrosamine Guidance and extension of timeframe for risk assessments

On 24 February 2021, the U.S. Food and Drug Administration announced a revision to its September 3, 2020, Guidance for Industry, Control of Nitrosamine Impurities in Human Drugs. The revision extends the recommended timeframe for manufacturers to assess the risk of nitrosamines in active pharmaceutical ingredients (APIs) and drug products from 6 to 7 months.


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25.02.2021 | NEWS

EUDAMED: Management of legacy devices

EUDAMED: Management of legacy devices

On 15 February 2021, the European Commission published a 13-page document on the management of legacy devices. It clarifies questions on how these will be identified in EUDAMED or how the different Unique Device Identifiers (UDI) will be generated or assigned.  


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19.02.2021 | NEWS

WHO: Draft Guideline on Medical Gases

WHO: Draft Guideline on Medical Gases

The WHO published a 29-page draft guideline on Good Manufacturing Practices for Medical Gases in February 2021. The reason given for this step is a sharp increase in the demand for medical gases, particularly oxygen used to provide respiratory care to covid patients.


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19.02.2021 | NEWS

EC: Italian Istituto Superiore di Sanità becomes 19. Notified Body

EC: Italian Istituto Superiore di Sanità becomes 19. Notified Body

As announced by the European Commission on 18 February 2021, the Italian Istituto Superiore di Sanità (ISS) has been designated as the 19. Notified Body under the EU Medical Devices Regulation (MDR) 2017/745.


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15.02.2021 | NEWS

EMA: GMP requirements for herbal extracts during early manufacturing steps

EMA: GMP requirements for herbal extracts during early manufacturing steps

EMA published the document "GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances" in February 2021.


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15.02.2021 | NEWS

EMA: Manufacturers to test rifampicin for nitrosamine impurities

EMA: Manufacturers to test rifampicin for nitrosamine impurities

Following the detection of 1-nitroso-4-methyl-piperazine (MeNP) impurities in some batches of rifampicin in February 2021, the EMA is requesting manufacturers to test the drug for the presence of MeNP. 


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05.02.2021 | NEWS

EMA: Pilot Project "OPEN" to Collaborate with Non-EU Authorities During COVID-19

EMA: Pilot Project "OPEN" to Collaborate with Non-EU Authorities During COVID-19

The European Medicines Agency (EMA) has launched an initiative to collaborate with non-EU authorities and WHO to drive the evaluation processes for COVID-19 vaccines and therapeutics.


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05.02.2021 | NEWS

PIC/S: Jordan applies for membership

PIC/S: Jordan applies for membership

As announced on 26 January 2021, the Jordan Food & Drug Administration (JFDA) has submitted a complete application for membership to the PIC/S.


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28.01.2021 | NEWS

PMDA: Information on the procedure for remote inspections

PMDA: Information on the procedure for remote inspections

In January 2021, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published the English translation of the document on remote inspections, Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products.


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28.01.2021 | NEWS

FDA: CDER agenda of all guidance documents planned for 2021

FDA: CDER agenda of all guidance documents planned for 2021

This year's Center for Drug Evaluation and Research (CDER) list of guidance documents scheduled for publication includes 18 categories with a total of 105 documents.


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22.01.2021 | NEWS

PICS/S: Four Aide-Mémoires updated

PICS/S: Four Aide-Mémoires updated

PIC/S has updated the following four Aide-Mémoires, which became effective on 1 January, 2021:


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21.01.2021 | NEWS

FDA: Janet Woodcock becomes acting commissioner

FDA: Janet Woodcock becomes acting commissioner

Dr. Janet Woodcock has been appointed as acting commissioner of the FDA. The previous commissioner, Dr. Stephen M. Hahn, stepped down from his role at the start of President Biden's term of office.


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19.01.2021 | NEWS

Mutual recognition of inspections under the EU-UK Trade Agreement

Mutual recognition of inspections under the EU-UK Trade Agreement

Questions about the EU-UK Trade and Cooperation Agreement, which will apply from January 1, 2021, were clarified by the European Commission in a 39-page Q&A on the EU-UK Trade and Cooperation Agreement on December 24, 2020. In total, it consists of 133 pairs of questions and answers.


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15.01.2021 | NEWS

PIC/S: Russia applies for membership

PIC/S: Russia applies for membership

The competent authorities of the Russian Federation submitted a complete membership application to PIC/S in Geneva on 13 January 2021. The rapporteur(s) will be appointed in written procedure or at the next meeting of the PIC/S Committee.


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15.01.2021 | NEWS

EC: Members appointed to MDR/IVDR expert panels

EC: Members appointed to MDR/IVDR expert panels

In the second week of January, the European Commission (EC) published a list of members appointed to the MDR and IVDR expert panels. On 10 September 2019, the 12 expert panels were designated by the Commission Implementing Decision (EU) 2019/1396.


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14.01.2021 | NEWS

EC allows remote audits by notified bodies

EC allows remote audits by notified bodies

On 11 January 2021, the European Commission (EC) announced what needs to be considered when Notified Bodies conduct remote audits of medical device and in vitro diagnostic manufacturers due to the COVID-19 situation.


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14.01.2021 | NEWS

Brexit: The transition phase is over - MHRA publishes 48 documents

Brexit: The transition phase is over - MHRA publishes 48 documents

The transition period until Brexit came into effect ended on 31 December 2020. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published another batch of documents for the processes that are now starting. They cover all aspects of the regulation of medicinal products and medical devices in the UK.


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14.01.2021 | NEWS

MHRA: UK and Canada – mutual recognition of GMP and batch testing certificates

MHRA: UK and Canada – mutual recognition of GMP and batch testing certificates

On 5 January 2021, the UK MHRA published a joint statement by the UK and Canada, which applies on an interim basis and is intended to avoid trade disruptions as a result of the Brexit. 


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21.12.2020 | NEWS

WHO: Draft guideline on technology transfer in pharmaceutical manufacturing

WHO: Draft guideline on technology transfer in pharmaceutical manufacturing

Shortly before the end of the year, WHO published a 38-page draft with twelve chapters and two appedices on technology transfer in pharmaceutical manufacturing.


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10.12.2020 | NEWS

MDCG: Q&A clarifies remote audit requirements for Notified Bodies

MDCG: Q&A clarifies remote audit requirements for Notified Bodies

In December 2020, the Medical Device Coordination Group (MDCG) of the European Commission published a six-page Q&A document on Notified Body audits of medical device manufacturers during the COVID 19 pandemic. 


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10.12.2020 | NEWS

UN: Cannabis removed from Schedule IV of most dangerous drugs

UN: Cannabis removed from Schedule IV of most dangerous drugs

As announced by the UN Commission on 2 December 2020, cannabis was removed from Schedule IV of the 1961 Single Convention on Narcotic Drugs following WHO's recommendation.


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04.12.2020 | NEWS

EU unveils the Pharmaceutical Strategy for Europe

EU unveils the Pharmaceutical Strategy for Europe

What should a crisis-proof drug supply in Europe resemble? In this regard, the European Commission presented a 25-page pharmaceutical strategy on November 25, 2020. It was awaited with great interest. One thing is for certain: the implementation of the strategy will not leave the EU pharmaceutical legislation unaffected.


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03.12.2020 | NEWS

PIC/S: Brazilian ANVISA becomes member

PIC/S: Brazilian ANVISA becomes member

As the PIC/S announced on 30 November 2020, the Brazilian National Health Authority 'Agência Nacional de Vigilância Sanitária' (ANVISA) has become the 54th member of PIC/S. 


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02.12.2020 | NEWS

EC: Fifth Notified Body according to IVDR

EC: Fifth Notified Body according to IVDR

The European Commission (EC) designated the German company TÜV Rheinland as a Notified Body under the In Vitro Diagnostics (IVDR) Regulation on 1 December 2020.


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27.11.2020 | NEWS

Swissmedic: Clarification on the validity of GMP certificates

Swissmedic: Clarification on the validity of GMP certificates

Swissmedic clarified on 20 November 2020 that GMP certificates issued after routine inspections in 2017 or 2018 are valid until 2021 or until the conduct of the next routine inspection.  


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25.11.2020 | NEWS

WHO: First draft guideline on GMP for research and development facilities

WHO: First draft guideline on GMP for research and development facilities

In November 2020, the WHO published a first draft on GMP for research and development facilities.


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20.11.2020 | NEWS

EMA: Nitrosamine limits for active ingredients now apply to the finished products

EMA: Nitrosamine limits for active ingredients now apply to the finished products

In a statement dated 13 November 2020, EMA announces that its CHMP (Committee for Medicinal Products for Human Use) has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines.


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20.11.2020 | NEWS

EMA: Emer Cooke takes over leadership position

EMA: Emer Cooke takes over leadership position

Emer Cooke from Ireland began her mandate as Executive Director of the EMA on November 16, 2020. On June 25, 2020 she was the first woman nominated for this position (we reported).


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20.11.2020 | NEWS

WHO: New draft on GMP for investigational products

WHO: New draft on GMP for investigational products

The WHO published a draft on GMP for investigational products in November 2020. The 28-page working document comprises 18 chapters and can be commented on until 6 January 2021. The guideline currently in force and consisting of 12 pages was published in 1996.  


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13.11.2020 | NEWS

Nitrosamine risk evaluation: Switzerland follows EU deadline extension

Nitrosamine risk evaluation: Switzerland follows EU deadline extension

On 9 November 2020, Swissmedic announced to further extend the deadline for the completion of a risk evaluation for medicinal products for human use with a risk of nitrosamine formation or (cross)contamination to 31 March 2021. For biological medicinal products, the final date for the completion of an evaluation is 1 July 2020. Switzerland is thus following the EU, which announced an extension of the deadline in early October.
 


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06.11.2020 | NEWS

Swissmedic: Adaptions to inspection routine due to Covid-19

Swissmedic: Adaptions to inspection routine due to Covid-19

Given the changed situation regarding COVID-19 and the differing measures introduced by the various cantons in Switzerland, Swissmedic has decided to adapt the way inspections in the healthcare field are carried out. As of 3 November 2020, inspections will only be performed after prior clarification of possible COVID-19-related capacity problems.


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30.10.2020 | NEWS

EMA: Implementation plan to reduce nitrosamine impurities

EMA: Implementation plan to reduce nitrosamine impurities

On 27 October 2020, the European Medicines Agency (EMA) published an implementation plan to reduce nitrosamine impurities in medicinal products.


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23.10.2020 | NEWS

EC: New webpage to Actor Registration Module for EUDAMED

EC: New webpage to Actor Registration Module for EUDAMED

The European Commission announces that the EUDAMED Actor Registration Module  will go live on 1 December 2020. Meanwhile a website has been set up to explain all the necessary steps to register  for access to EUDAMED and the following modules.


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23.10.2020 | NEWS

EMA calls for nitrosamine testing of metformin-containing drugs

EMA calls for nitrosamine testing of metformin-containing drugs

All marketing authorisation holders for metformin-containing medicines will be asked by the EMA or the national competent authorities to test their medicines for the presence of nitrosamines before releasing them to the market. This is to be a preventive measure, as stated in the notification on the EMA website.


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16.10.2020 | NEWS

British MHRA becomes new member of the ACSS Consortium

British MHRA becomes new member of the ACSS Consortium

The ACSS Consortium, a joint initiative of the regulatory authorities of Australia (TGA), Canada (HC), Singapore (HSA) and Switzerland (Swissmedic) announces a new membership: the British MHRA. Following as short observatory role, the MHRA will officially start to work with the consortium partners on January 1, 2021.Along with this, the group has changed its name to accommodate the new partner, and will be known as the "Access Consortium". The new name reflects the group’s key aim of providing patients with timely ‘access’ to high quality, safe and effective therapeutic products across the five countries.


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02.10.2020 | NEWS

EMA reports extension of deadline for nitrosamine risk assessment

EMA reports extension of deadline for nitrosamine risk assessment

The EMA (European Medicines Agency) announces that the deadline for the completion of a risk assessment for all chemically defined human medicinal products that bear the risk of nitrosamine formation or (cross)contamination will be extended until 31 March 2021. For biological medicinal products, the final date for completion of a risk assessment will be 1 July 2020.


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02.10.2020 | NEWS

ICH: Q3D(R2) for elemental impurities reaches Step 2

ICH: Q3D(R2) for elemental impurities reaches Step 2

The draft for the ICH Q3D(R2) Guideline for Elemental Impurities has reached Step 2 on September 25, 2020 and thus the consultation phase. The draft guideline includes, amongst others, corrected PDE values for gold, silver and nickel and a new appendix for impurities that are applied cutaneously or transcutaneously.  


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25.09.2020 | NEWS

Swissmedic: Warning from Brazil due to counterfeit medicinal products from Turkish wholesalers

Swissmedic: Warning from Brazil due to counterfeit medicinal products from Turkish wholesalers

The Brazilian health regulatory agency, ANVISA, warns of counterfeit medicinal products for which import was banned immediately.
This was announced by Swissmedic, who was informed directly by ANVISA on 23 September 2020. 


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25.09.2020 | NEWS

CHMP confirms recommendation on ranitidine medicines

CHMP confirms recommendation on ranitidine medicines

On 18 September 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its recommendation to suspend all ranitidine-containing medicinal products in the EU due to the presence of low levels of the impurity N-nitrosodimethylamine (NDMA).This follows a re-examination of CHMP’s April 2020 opinion, which was requested by one of the companies marketing ranitidine medicines. The EMA has published a detailed statement on this recommendation.


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18.09.2020 | NEWS

Now published: EN 17141:2020 Cleanrooms and associated controlled environments – biocontamination control

Now published: EN 17141:2020 Cleanrooms and associated controlled environments – biocontamination control

The new European standard EN 17141:2020 has been issued on 12 August 2020 and will replace the DIN EN ISO 14698 (Parts 1 and 2) of the year 2003, which no longer reflects the state of the art.


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07.09.2020 | NEWS

Swissmedic: On-site inspections on a regular basis again

Swissmedic: On-site inspections on a regular basis again

The Swiss Agency for Therapeutic Products, Swissmedic, will, according to an announcement made on 1 September 2020, carry out regular GMP and GDP inspections on site again with immediate effect. Protective measures such as distance and hygiene rules must continue to be followed and infections must be traced.


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04.09.2020 | NEWS

FDA: Comprehensive Guidance on Control of Nitrosamine Impurities

FDA: Comprehensive Guidance on Control of Nitrosamine Impurities

How can manufacturers of pharmaceuticals and APIs detect and prevent nitrosamine impurities in pharmaceutical products and what are possible causes of the contaminations? These questions have been occupying regulatory authorities and of course the pharmaceutical industry for the last two years. Answers are now provided by the 24-page guidance on Control of Nitrosamine Impurities in Human Drugs, which was published by the US FDA on 1 September 2020.


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03.09.2020 | NEWS

MHRA publishes numerous guidelines for post-brexit period

MHRA publishes numerous guidelines for post-brexit period

On 1 September 2020, the British MHRA (Medicines and Healthcare products Regulatory Agency) published numerous guidelines explaining how medicinal products, active ingredients, medical devices or clinical trials are to be regulated after the brexit transition period ends on 1 January 2021.


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28.08.2020 | NEWS

EC: Updated version 18 of Q&A on safety features for medicinal products for human use

EC: Updated version 18 of Q&A on safety features for medicinal products for human use

On August 12, 2020, the European Commission published version 18 of the Q&A on safety characteristics for medicinal products. The document, which has now grown to 34 pages, was thus the second update this year (we reported).
New are the questions 4.6, 5.12, 5.13 and 6.9, which are briefly summarized below: 


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28.08.2020 | NEWS

FDA: Q&A for the manufacture of drugs and biological products, their supply chain and inspections during COVID-19

FDA: Q&A for the manufacture of drugs and biological products, their supply chain and inspections during COVID-19

On August 19, 2020, the US FDA issued a 12-page guideline for the pharmaceutical industry in the form of a Q&A, which deals specifically with questions regarding  

  • Manufacturing  
  • Requirements for the supply chain  
  • Inspections  
  • Pending applications for approval and  
  • Changes in manufacturing facilities for already approved medicinal products  

during COVID-19. 


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21.08.2020 | NEWS

MHRA inspections: Deficiencies and expectations on HBELs and cross contaminations – PIC/S AiM and Q&A provide answers

MHRA inspections: Deficiencies and expectations on HBELs and cross contaminations – PIC/S AiM and Q&A provide answers

On its Inspectorate Blog, the UK MHRA (Medicines and Healthcare products Regulatory Agency) has critically reviewed the implementation of the requirements on HBELs and the prevention of cross contamination in shared facilities. What are the expectations to be met and what deficiencies have been identified in recent inspections?

According to the MHRA Inspectorate Blog, answers can be found in these two PIC/S documents:


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14.08.2020 | NEWS

WHO: Three new draft guidelines published

WHO: Three new draft guidelines published

The World Health Organisation (WHO) has published three new draft guidelines, which are currently available for comments. In September 2020, all comments will be consolidated and reviewed. The documents will then be prepared for discussion and presented at the 55th virtual meeting of the ECSPP (WHO Expert Committee on Specifications for Pharmaceutical Preparations). It is scheduled to take place from 12 to 16 October 2020.


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14.08.2020 | NEWS

MHRA: Risk-based resumption of on-site inspections in September

MHRA: Risk-based resumption of on-site inspections in September

After the US FDA already announced the gradual resumption of on-site surveillance inspections in May (we reported), the MHRA is now also following this course. The short Guidance for industry on MHRA's expectations for return to UK on-site inspections published on 11 August 2020 sets out the procedure.   


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07.08.2020 | NEWS

EMA: MRA partners may participate in JAP audits as co-auditors

EMA: MRA partners may participate in JAP audits as co-auditors

As of July 2020 the EMA (European Medicines Agency) has amended the European "Joint Audit Programme, JAP". These adaptations enable regulatory authorities from third countries with an existing EU-MRA (Mutual Recognition Agreement) to participate as co-auditors in JAP audits of EEA GMP inspectorates.


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07.08.2020 | NEWS

EMA: New Q&A on nitrosamine impurities for marketing authorisation holders

EMA: New Q&A on nitrosamine impurities for marketing authorisation holders

Shortly after the publication of the EMA's final assessment report on nitrosamine impurities in medicinal products (we reported), a 15-page Q&A for marketing authorisation holders and applicants was published on 6 August 2020.

It replaces the document 'Information on nitrosamines for marketing authorisation holders' EMA/428592/2019 published in September 2019, which was withdrawn.   


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22.07.2020 | NEWS

EMA: New guideline on the quality of water for pharmaceutical use

EMA: New guideline on the quality of water for pharmaceutical use

On 20 July 2020, EMA published the final 10-page Guideline on the quality of water for pharmaceutical use.
The date of entry into force will be 1 February 2021.


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22.07.2020 | NEWS

EMA: Final assessment report on nitrosamines

EMA: Final assessment report on nitrosamines

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has published a final assessment report on nitrosamine impurities.


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17.07.2020 | NEWS

Switzerland: New MepV and KlinV-Mep adopted

Switzerland: New MepV and KlinV-Mep adopted

On 1 July 2020, the Swiss Federal Council adopted the revised Ordinance on Medical Devices (MedDO) and the new Ordinance on Clinical Trials for Medical Devices (ClinO-MD).   


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10.07.2020 | NEWS

French GMED becomes 15th Notified Body under MDR

French GMED becomes 15th Notified Body under MDR

The French company GMED, based in Paris was designated 15th Notified Body under the new Medical Devices Regulation (MDR) on July 8, 2020.


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10.07.2020 | NEWS

New EMA Executive Director: Emer Cooke from Ireland

New EMA Executive Director: Emer Cooke from Ireland

On 25 June 2020, the Management Board of the European Medicines Agency (EMA) selected the Irish pharmacist Emer Cooke as the new EMA Executive Director from a list of candidates prepared by the European Commission.


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03.07.2020 | NEWS

EMA and Korean MFDS share confidential COVID-19 information

EMA and Korean MFDS share confidential COVID-19 information

EMA and the Korean Ministry of Food and Drug Safety (MFDS) have signed an agreement to exchange confidential information on medicines for the treatment, diagnosis or prevention of COVID-19.


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02.07.2020 | NEWS

EMA: Further update of Q&A on regulatory GMP-requirements during COVID-19

EMA: Further update of Q&A on regulatory GMP-requirements during COVID-19

The European Commission, the EMA and the European Network of Medicines Regulatory Authorities have published the third version of the Q&A on regulatory expectations for medicinal products for human use during the COVID-19 pandemic on July 1, 2020. The document has meanwhile grown from originally 7 to now 23 pages and intends to serve pharmaceutical companies as a guide on current adjustments to the regulatory framework due to COVID-19.


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25.06.2020 | NEWS

Nitrosamines: Lessons learnt from sartan medicines

Nitrosamines: Lessons learnt from sartan medicines

On 23 June 2020, the European medicines regulatory network published the outcome of a lessons learned exercise on the presence of nitrosamines in sartan medicines. This includes recommendations to help reduce the risk of impurities in medicines, and to ensure that regulators are better prepared to manage cases of unexpected impurities. The report is called "Lessons learnt from presence of N-nitrosamine impurities in sartan medicines".


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19.06.2020 | NEWS

TÜV SÜD Product Service becomes fourth Notified Body under IVDR

TÜV SÜD Product Service becomes fourth Notified Body under IVDR

As announced by TÜV Süd Product Service GmbH on 17 June 2020, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) designated the company as the fourth Notified Body according to the In Vitro Diagnostic Regulation (IVDR).


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18.06.2020 | NEWS

WHO: Three new draft guidelines for commentary

WHO: Three new draft guidelines for commentary

In May 2020, the WHO published the following three drafts for commentary: 


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04.06.2020 | NEWS

EC presents concept for the supply of medicinal products for comment

EC presents concept for the supply of medicinal products for comment

On 3rd June 2020, the European Commission published a concept for the safe and affordable supply of medicinal products in Europe. 
The initiative Pharmaceutical Strategy - Timely patient access to affordable medicines is designed to facilitate innovation in the pharmaceutical industry. 


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29.05.2020 | NEWS

WHO publishes Technical Report Series No. 1025, 2020

WHO publishes Technical Report Series No. 1025, 2020

The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (Technical Report Series) include all adopted guidelines in form of Annexes.

With the publication of the 54th Technical Report Series No. 1025 of the WHO, several new and revised Guidelines were adopted and recommended for use.


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29.05.2020 | NEWS

EMA: Update of Q&A on flexible regulatory GMP/GDP requirements during COVID-19

EMA: Update of Q&A on flexible regulatory GMP/GDP requirements during COVID-19

A second revised version of the Q&A document was published on May 26, 2020. A new block of questions (sub-point 6) with six questions and answers deals with the additional temporary flexibility in the GMP/GDP area.


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19.05.2020 | NEWS

MDR: Intertek from Sweden becomes 14th notified body

MDR: Intertek from Sweden becomes 14th notified body

The Swedish company Intertek announced on 15 May 2020 that Intertek Medical Notified Body AB (IMNB) has been designated as the 14th Notified Body against the EU Medical Device Regulation 2017/745 (MDR). 


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15.05.2020 | NEWS

US FDA: Gradual restart of surveillance inspections

US FDA: Gradual restart of surveillance inspections

The US FDA is planning a gradual re-start of on-site surveillance inspections in cooperation with the Centers for Disease Control and Prevention (CDC).


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15.05.2020 | NEWS

EU GMP: Consultation Deadline for Annex 21 Extended to August

EU GMP: Consultation Deadline for Annex 21 Extended to August

On 15 May 2020, the European Commission has announced to extend the time frame for the consultation on Annex 21 Importation of Medicinal Products until 20 August 2020. This step is justified by the challenges arising in connection with COVID-19.


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08.05.2020 | NEWS

EMA: Suspension of ranitidine medicines

EMA: Suspension of ranitidine medicines

As the EMA announced on 30 April 2020, all ranitidine medicines in the EU are to be taken off the market. 


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05.05.2020 | NEWS

EU GMP: Consultation Deadline for Annex 1 Extended to July

EU GMP: Consultation Deadline for Annex 1 Extended to July

On 30 April 2020, the European Commission has announced to extend the time frame for the second consultation on Annex 1 Manufacture of Sterile Products until 20 July 2020. This step is justified by the challenges arising in connection with COVID-19.


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30.04.2020 | NEWS

CMDh: Decentralised procedures and mutual recognition during COVID-19

CMDh: Decentralised procedures and mutual recognition during COVID-19

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of the EMA has published a Q&A for the practical handling of processes for mutual recognition of authorisations during the COVID 19 crisis. 


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24.04.2020 | NEWS

British MHRA temporarily relaxes GMP regulation

British MHRA temporarily relaxes GMP regulation

In order to address the current exceptional circumstances, the UK regulatory authority MHRA has opted for a temporary flexibility on good manufacturing practice (GMP). The authority considers these steps necessary to meet the current  supply needs of medicines in the UK. In this context, the GDP requirements for wholesalers have already been relaxed and the discretionary scope for QPs has also been extended.


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24.04.2020 | NEWS

EU MDR: Decision on delay by one year

EU MDR: Decision on delay by one year

On 17 April 2020, the European Parliament voted by 693 to one votes and with two abstentions to delay the entry into force of the EU Medical Device Regulation (MDR) by one year - to 26 May 2021. 


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17.04.2020 | NEWS

MDR and ICH Q12: Switzerland's adaptation to the EU

MDR and ICH Q12: Switzerland's adaptation to the EU

How is Switzerland adapting to the EU regarding the implementation of MDR, IVDR and ICH Q12?
 


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17.04.2020 | NEWS

EMA and COVID-19: Task Force and Q&A on flexible regulatory requirements for pharmaceutical companies

EMA and COVID-19: Task Force and Q&A on flexible regulatory requirements for pharmaceutical companies

The European Commission, the EMA and the European Medicines Regulatory Network have developed a 7-page Q&A to guide pharmaceutical companies in making flexible adjustments to the regulatory framework during the COVID 19 pandemic. The EMA has established a task force for this purpose, to take quick and coordinated regulatory action.


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09.04.2020 | NEWS

EC: New ways to conduct Notified Body-audits during COVID-19

EC: New ways to conduct Notified Body-audits during COVID-19

On 8 April 2020, the Medical Device Coordination Group (MDCG) published a five-page guideline on the conduct of audits by Notified Bodies to be applied during the COVID 19 pandemic. 


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07.04.2020 | NEWS

ICH publishes ICH Q3C(R8) with three new PDES for comments

ICH publishes ICH Q3C(R8) with three new PDES for comments

The ICH Q3C(R8) draft Guideline on Impurities: Guideline for Residual Solvents, has reached Step 2b and now enters the consulation period.

The draft document contains solemly the Permitted Daily Exposure (PDE) levels for

  • 2-Methyltetrahydrofuran (proposed is a PDE of 50 mg/day and a placement in Class 3 solvents)
  • Cyclopentyl Methyl Ether (proposed is a PDE of 15 mg/day and a placement in Class 2 solvents)
  • Tertiary Butyl Alcohol (proposed is a PDE of 35 mg/day and a placement in Class 2 solvents).

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30.03.2020 | NEWS

MDR: Proposal for a delay due to Covid-19

MDR: Proposal for a delay due to Covid-19

The deadline of 26 May 2020 should have been the date: The European Commission's Medical Device Regulation (MDR) was supposed to come into force. Due to the Corona crisis, the European Commission is now submitting a proposal to postpone the implementation deadline.


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30.03.2020 | NEWS

Draft of EU-GMP Annex 21: Import of medicinal products published

Draft of EU-GMP Annex 21: Import of medicinal products published

The European Commission published the 4-page draft version of the new Annex 21: Importation of medicinal products, on 20 March 2020. Apart from the main Chapters and Annexes of the EU GMP Guide, it has become necessary to establish specific guidelines for the activity of importing medicinal products.


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29.03.2020 | NEWS

Extended deadline for risk assessment of nitrosamine impurities

Extended deadline for risk assessment of nitrosamine impurities

The European Medicines Agency (EMA) announced that the deadline for the submission of risk assessments for all human medicines presenting a risk for the presence of nitrosamine impurities or (cross)contaminations will be extended to 1 October 2020. The announcement was made just one day ahead of the original deadline scheduled for 26 March 2020. This will give all companies affected more time to review their manufacturing processes and carry out the required risk assessments.

The reason given for this step is the challenges and impact of the restrictions in place to combat the COVID 19 pandemic.

 


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27.03.2020 | NEWS

Updated version 17 of the Q&A on safety features for medicinal products for human use

Updated version 17 of the Q&A on safety features for medicinal products for human use

On March 9, 2020, the European Commission published version 17 of the Q&A on safety features for medicinal products. The document is updated on a regular basis (we reported).


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20.03.2020 | NEWS

Australian TGA Suspends Overseas GMP Inspections

Australian TGA Suspends Overseas GMP Inspections

The Australian Therapeutic Goods Administration (TGA) has suspended all foreign GMP inspections and QMS (Quality Management System) audits until further notice.


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19.03.2020 | NEWS

FDA: Domestic routine inspections postponed due to Covid-19

FDA: Domestic routine inspections postponed due to Covid-19

The US FDA had already announced on 10 March 2020 that most foreign inspections would be postponed until April with immediate effect. Now domestic routine surveillance inspections will also be scaled back.


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13.03.2020 | NEWS

FDA: Foreign Inspections postponed due to Coronavirus

FDA: Foreign Inspections postponed due to Coronavirus

The US FDA announced that it is postponing most foreign inspections through April with immediate effect due to the Coronavirus disease. Inspections outside the US that are considered critical will be reviewed by the FDA on a case-by-case basis.


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06.03.2020 | NEWS

India: Restricted exports of APIs due to coronavirus

India: Restricted exports of APIs due to coronavirus

As the Indian Directorate General of Foreign Trade announced on 3 March 2020, the export of 26 active ingredients and medicinal products will be severely restricted until further notice due to the global spread of the coronavirus.


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06.03.2020 | NEWS

EMA: What EU adaptations are necessary for ICH Q12?

EMA: What EU adaptations are necessary for ICH Q12?

The ICH Q12 guideline on technical and regulatory considerations for pharmaceutical product lifecycle management was adopted by the CHMP (European Committee for Medicinal Products for Human Use) in January 2020. On March 4,  the EMA (European Medicines Agency) published a two page note on the implementation of ICH Q12. It addresses the fact that there are conceptual differences between ICH Q12 and the EU legal framework. Therefore, a 1:1 application in the EU is not possible without further ado.


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28.02.2020 | NEWS

ICH Q12: Introductory Training Presentation published

ICH Q12: Introductory Training Presentation published

ICH has published a training presentation on ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle compiled by the Q12 Expert Working Group.


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28.02.2020 | NEWS

Operation Broadsword: US FDA and Indian Government combat illegal drugs

Operation Broadsword: US FDA and Indian Government combat illegal drugs

The US FDA, in cooperation with the Indian authorities, has seized 500 shipments of illegal and potentially dangerous unapproved prescription drugs and medical devices. The products were in transit to American consumers by international mail.


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21.02.2020 | NEWS

EU GMP Annex 1: Second Draft on Sterile Manufacture

EU GMP Annex 1: Second Draft on Sterile Manufacture

A first targeted consultation to the Annex 1 of the EU GMP Guide allowed about 140 companies and organizations to comment. The drafting group processed more than 6200 lines of comments. These have now been taken into account in the preparation of a second draft.


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14.02.2020 | NEWS

MDR: National Standards Authority of Ireland (NSAI) is 11th Notified Body

MDR: National Standards Authority of Ireland (NSAI) is 11th Notified Body

The Dublin-based National Standards Authority of Ireland (NSAI) was designated by the European Commission as the eleventh Notified Body under MDR and thus added to the NANDO database.


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14.02.2020 | NEWS

ICH: Plans to harmonize with PIC/S and WHO

ICH: Plans to harmonize with PIC/S and WHO

The International Council for Harmonisation (ICH) has made the Minutes of the ICH Assembly Meeting in Singapore, in November 2019, publicly available. In contrast to the already published press release (we reported), the meeting minutes include new details on the following interesting projects for the GMP area:


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07.02.2020 | NEWS

MDR: Norwegian DNV GL Presafe AS is 10th Notified Body

MDR: Norwegian DNV GL Presafe AS is 10th Notified Body

The Norwegian DNV GL Presafe AS (Notified Body 2460) is now a Notified Body for EU Medical Devices Regulation (MDR) 2017/745.


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06.02.2020 | NEWS

EMA: Information on Brexit

EMA: Information on Brexit

In a press release the EMA informs pharmaceutical and medical device manufacturers about the withdrawal of Great Britain from the EU on 31 January 2020. What are the current developments?


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03.02.2020 | NEWS

News on our behalf: new name, new logo

News on our behalf: new name, new logo

As you may have already noticed - on our website or elsewhere - we have a new company logo and also a new name.


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31.01.2020 | NEWS

FDA: CDER list of all guidelines planned for 2020

FDA: CDER list of all guidelines planned for 2020

This year's list of guidelines to be published by the CDER (Center for Drug Evaluation and Research) comprises 14 categories with a total of 89 documents. 


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24.01.2020 | NEWS

EMA: Reflection Paper on GMP-related responsibilities of MAHs

EMA: Reflection Paper on GMP-related responsibilities of MAHs

On 14 January 2020, the EMA published a draft Reflection Paper on the GMP-related obligations of marketing authorisation holders (MAHs). In general, these responsibilities relate to outsourcing and technical agreements. However, they are spread over the different chapters and annexes of the EU GMP Guideline and are also quite numerous. The aim of the reflection paper now is to clarify in a single document what the different responsibilities are and what they mean for MAHs at a practical level. It also addresses the legal provisions in European Directives and other Directives that relate to GMP and also affect marketing authorisation holders.


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17.01.2020 | NEWS

FDA approves new ISO Standard 14971:2019 for medical devices

FDA approves new ISO Standard 14971:2019 for medical devices

In December 2019, the International Organization for Standardization (ISO) published the revised standard ISO 14971:2019 on application of risk management to medical devices. This standard has now been added to the list of Recognized Consensus Standards by the US FDA.


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10.01.2020 | NEWS

EMA: Update of Q&A on EU-US MRA

EMA: Update of Q&A on EU-US MRA

In December 2019, the European Medicines Agency (EMA) revised a four-page Q&A document on the EU-US Mutual Recognition Agreement (MRA) on marketing authorisation applications and variations.


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10.01.2020 | NEWS

EMA: Revised Q&A on Nitrosamine Contamination

EMA: Revised Q&A on Nitrosamine Contamination

End of December 2019, the EMA has updated the Q&A document for marketing authorisation holders who are currently reviewing their medicines for the possible presence of nitrosamines and testing products at risk.


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13.12.2019 | NEWS

Dr. Stephen Hahn elected as new FDA commissioner

Dr. Stephen Hahn elected as new FDA commissioner

On 12 December 2019, the US Senate elected Dr. Stephen Hahn as the 24th Commissioner of the US FDA (Food and Drug Administration) by 72 to 18 votes.


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06.12.2019 | NEWS

Sartan monographs of the European Pharmacopoeia revised due to nitrosamine impurities

Sartan monographs of the European Pharmacopoeia revised due to nitrosamine impurities

During the last months, there have been repeated cases of nitrosamine contamination in sartans (we reported). As a consequence, the sartan monographs of the European Pharmacopoeia were revised: Transiently, new strict limits apply for the contamination of sartans with nitrosamines. The monographs will come into force on January 1, 2020.


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06.12.2019 | NEWS

EC: Eight technical guidelines for individual identifiers (UDIs)

EC: Eight technical guidelines for individual identifiers (UDIs)

On 4 December 2019, the European Commission published eight documents containing technical specifications for unique device identifiers (UDIs). 


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29.11.2019 | NEWS

EC: Second corrigendum to MDR concerns Class I medical devices

EC: Second corrigendum to MDR concerns Class I medical devices

On 25 November 2019, the European Commission published the second corrigendum to the EU Medical Devices Regulation (MDR). The corrections mainly concern Class I medical devices. 


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29.11.2019 | NEWS

ICH: What's new?

ICH: What's new?

The ICH (International Council for Harmonisation) met in Singapore from 16-20 November 2019. More than 450 participants attended the meeting and fourteen Working Groups met to progress their work.

A particularly noteworthy milestone is:

  • ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was finalised in Singapore and has reached Step 4 of the ICH process.

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22.11.2019 | NEWS

EC: Aide-Mémoire on GDP Inspections of Wholesalers

EC: Aide-Mémoire on GDP Inspections of Wholesalers

On 18 November 2019, the European Commission published the "Aide-Mémoire for GDP inspection of wholesalers compliance with commission delegated regulation (EU) 2016/161 for safety features". As a checklist, the six-page document is intended to assist wholesalers in complying with the relevant GDP regulations on safety features.


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22.11.2019 | NEWS

WHO: Draft Guideline on Data Integrity

WHO: Draft Guideline on Data Integrity

In late October 2019, the WHO published a 28-page draft guideline on data integrity. It clarifies basic aspects to ensure reliable data and information in the manufacture and control of medicinal products. A 7-page annex provides additional examples for the practical implementation of the requirements.
 


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08.11.2019 | NEWS

Swissmedic adapts requirements for combination products to EU

Swissmedic adapts requirements for combination products to EU

The Swiss Agency for Therapeutic Products (Swissmedic) is working on adapting the requirements for combination products to the new EU Medical Devices Regulation (MDR). A notification was published on the Swissmedic website on 5 November 2019.


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08.11.2019 | NEWS

ICH: What about the implementation of the ICH guidelines worldwide?

ICH: What about the implementation of the ICH guidelines worldwide?

On 4 November 2019, the ICH has published the survey results on the level of implementation and adherence to ICH Guidelines within its Regulatory Member and Observer countries. The results have been compiled in a 26 page report. Especially interesting is the resulting tabular overview of the data including a search function:


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31.10.2019 | NEWS

Introduction of EUDAMED postponed to 2022

Introduction of EUDAMED postponed to 2022

On its website, the European Commission has officially announced that the launch of the European Database on Medical Devices, EUDAMED, has been postponed:


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29.10.2019 | NEWS

EMA: Updated and revised Q&A on MDR and IVDR

EMA: Updated and revised Q&A on MDR and IVDR

On 22 October 2019, the European Medicines Agency (EMA) released an revised and updated Q&A on the implementation of the EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR).


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11.10.2019 | NEWS

ICH: ICH Q3C(R6) reinstated with original ethylene glycol PDE

ICH: ICH Q3C(R6) reinstated with original ethylene glycol PDE

According to the ICH, the PDE value for ethylene glycol was reinstated to its previous PDE value of 6,2 mg/day and a concentration limit of 620 ppm. This value was changed in October 2018 with the ICH Q3C(R7) version  to a PDE of 3.1 mg/day and a concentration limit of 310 ppm. The process was then preceded by an error correction procedure (we reported).


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11.10.2019 | NEWS

EC: Dekra becomes first Notified Body according to IVDR

EC: Dekra becomes first Notified Body according to IVDR

On 10 October 2019, the European Commission announced the first Notified Body designated under the EU Vitro Diagnostics Regulation (IVDR).


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04.10.2019 | NEWS

Revised Version 16 of Q&A on Safety Features for Medicinal Products for Human Use

Revised Version 16 of Q&A on Safety Features for Medicinal Products for Human Use

The updates on this document are overturning: On 25 September 2019, the European Commission published Version 16 of the document on safety features for medicinal products for human use. 


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25.09.2019 | NEWS

TÜV SÜD certifies first Class III medical device according to MDR

TÜV SÜD certifies first Class III medical device according to MDR

On 19 September, the notified body TÜV SÜD announced the certification of the first Class III medical device in accordance with the new EU Medical Devices Regulation (MDR).


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20.09.2019 | NEWS

Novartis Inhaler: First Medical Device Certified under MDR

Novartis Inhaler: First Medical Device Certified under MDR

On 3 September 2019, the UK notfied body BSI announced the Novartis Concept1 inhaler as first medical device certified under the new EU Medical Devices Regulation (MDR).


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16.09.2019 | NEWS

How is the harmonisation of ISO 13485 and US 21 CFR 820 going?

How is the harmonisation of ISO 13485 and US 21 CFR 820 going?

The United States FDA works on the harmonisation of the Quality System Regulation, 21 CFR 820 with ISO 13485, the international standard for quality management of medical devices (we reported), saying that


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06.09.2019 | NEWS

EMA: Limits for further nitrosamines in sartans

EMA: Limits for further nitrosamines in sartans

In summer 2018, production-related contamination of the antihypertensive valsartan with the nitrosamines NDMA and NDEA caused a stir in the pharmaceutical world (we reported). A risk assessment conducted by the European Medicines Agency (EMA) followed this. The results can be found in the detailed EMA report from February 2019.


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29.08.2019 | NEWS

Import of ATMPs: EMA Q&A for exemptions in re-testing batches

Import of ATMPs: EMA Q&A for exemptions in re-testing batches

A Q&A published by the European Medicines Agency (EMA) on 28 August 2019 clarifies when exemptions from batch re-testing of imported advanced therapy medicinal products (ATMPs) are permitted.


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23.08.2019 | NEWS

US FDA reports fake inspection documents of Chinese OTC manufacturer

US FDA reports fake inspection documents of Chinese OTC manufacturer

On August 20, 2019, the US FDA published a warning letter to Ningbo Huize Commodity Co., a Chinese manufacturer of OTC drugs. The case concerns serious violations of good manufacturing practice and, in this context, the serious manipulation of data. In addition to this the FDA has gone public with detailed information.


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21.08.2019 | NEWS

Italian IMQ Istituto Named Fourth Notified Body under MDR

Italian IMQ Istituto Named Fourth Notified Body under MDR

As announced by the European Commission on 20 August 2019, the IMQ Istituto located in Milan, Italy, has been notified as the fourth Notified Body under the new European MDR to come in 2020. This is still too little, according to the opinion within the medical device industry.


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15.08.2019 | NEWS

German DEKRA listed as third Notified Body under new MDR

German DEKRA listed as third Notified Body under new MDR

In addition to BSI UK and TÜV Süd, the German DEKRA Certification GmbH is now recognised as a third Notified Body for the EU Regulation 2017/745 (MDR).


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08.08.2019 | NEWS

Implementation of the EU MDR/IVDR: USA also raises concerns

Implementation of the EU MDR/IVDR: USA also raises concerns

According to RAPS, a US-statement to the Committee for Technical Barriers to Trade of the World Trade Organization (WTO) from 24 July 2019, raises concerns regarding the implementation of the new European Medical Devices Regulation (MDR) and the Regulation on In Vitro Diagnostics (IVDR). The MDR is already due to enter into force on 26 May 2020, the IVDR in 2022.


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02.08.2019 | NEWS

Brexit: EC reminder on batch testing transfer of medicinal products to EU by 2020

Brexit: EC reminder on batch testing transfer of medicinal products to EU by 2020

From today’s perspective, the UK will be a third country as of 1 November 2019. As a result, all  batch  testing  facilities will have to be fully transferred to the EU27/EEA by  1  January  2020.  The European Commission has now published a reminder announcement regarding the requirement of batch release sites to be established in the EU. This applies also to MAHs which were granted an exemption to continue relying on quality control testing performed in the UK earlier this year (we reported).


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29.07.2019 | NEWS

MDR/IVDR: Australian TGA keeps tabs on shortage of European NBs

MDR/IVDR: Australian TGA keeps tabs on shortage of European NBs

The TGA (Australian Therapeutic Goods Administration) has expressed concern about a looming shortage of Notified Bodies under the new Medical Device and In Vitro Diagnostics Regulations (MDR/IVDR) in Europe. Not without reason, though.


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16.07.2019 | NEWS

MRA EU/USA: Goal achieved - all EU member states recognized

MRA EU/USA: Goal achieved - all EU member states recognized

As the EMA announced on 12 July 2019, Slovakia is the last EU member state to be recognized by the USA under the Mutual Recognition Agreement (MRA).


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12.07.2019 | NEWS

British Medicines Agency Recalls Medicines with Missing Safety Labels

British Medicines Agency Recalls Medicines with Missing Safety Labels

In England, imported medicines have appeared which have apparently been removed or "stolen" from the legal supply chain in order to be reintroduced later into regular sales. With this, both correct transport and appropriate storage conditions are no longer guaranteed.


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05.07.2019 | NEWS

MDR/IVDR: Two guideances published on Art. 15 and 18

MDR/IVDR: Two guideances published on Art. 15 and 18

On 1 July 2019, the Medical Device Coordination Group (MDCG) published two guidance documents on the Medical Device Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR).


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28.06.2019 | NEWS

EU/US MRA: Germany finally recognised as 27th EU Member State

EU/US MRA: Germany finally recognised as 27th EU Member State

On 26 June 2019, the US FDA granted Germany the ability to carry out GMP inspections at a level equivalent to that of the USA. With this, the MRA between the US and the EU has almost reached its goal: By 15 July 2019, the recognition of all 28 EU Member States should be completed.


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28.06.2019 | NEWS

EMA Q&A regarding OOS-batches of ATMPs

EMA Q&A regarding OOS-batches of ATMPs

The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT), together with the GMDP Inspectors Working Group and the Blood Products Working Party, released a Q&A document on how companies should handle OOS batches of authorized cell or tissue-based advanced therapy medicinal products (ATMPs). For manufacturers, importers and Marketing Authorisation Holders of ATMPs this 2-page document will be of good value.


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25.06.2019 | NEWS

EU MDR/IVDR: Everything on its way?

EU MDR/IVDR: Everything on its way?

Across the EU, an increasing number of discussions are highlighting concern about the challenges facing each stakeholder in the sector (manufacturers, notified bodies, authorised representatives, distributors, competent authorities, European Commission) in implementing the new MDR/IVDR Regulations on time and effectively.


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21.06.2019 | NEWS

ICH: What's new?

ICH: What's new?

The ICH (International Council for Harmonisation) met from 1 to 6 June 2019 in Amsterdam, Netherlands. 


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18.06.2019 | NEWS

BfArM reports further Xarelto® counterfeits

BfArM reports further Xarelto® counterfeits

Once again, two counterfeit batches of the drug Xarelto® 20 mg from the original manufacturer Bayer AG in Polish-Slovak packaging were discovered at a parallel distributor in Great Britain. Xarelto®, with the active ingredient Rivaroxaban, is used to prevent strokes and systemic embolisms as well as to treat pulmonary embolisms and venous thromboses.


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14.06.2019 | NEWS

EU/US MRA on inspections: Luxembourg and the Netherlands accepted

EU/US MRA on inspections: Luxembourg and the Netherlands accepted

On 10 June 2019, the FDA has confirmed the capability, capacity and procedures in place of Luxembourg and the Netherlands to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 26 EU member states, whose inspection results will be trusted in the future. This process is to be completed for all EU states by 15 July 2019.


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07.06.2019 | NEWS

EC: 20 Questions & Answers about Notified Bodies

EC: 20 Questions & Answers about Notified Bodies

On 6 June 2019, the European Commission published a Q&A document to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs).

The 8-page document has been endorsed by the Medical Device Coordination Group (MDCG). The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

It answers four sets of questions on a range of MDR/IVDR requirements relating to NBs. The clarifications cover organizational and general requirements, as well as resources requirements and process requirements.


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03.06.2019 | NEWS

WHO: Technical Report Series 1019, 2019 published

WHO: Technical Report Series 1019, 2019 published

The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (Technical Report Series) include all adopted guidelines in the form of Annexes.

With the publication of the 53nd Technical Report Series No. 1019 of the WHO, several new and revised Guidelines were adopted and recommended for use.


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27.05.2019 | NEWS

TÜV SÜD designated as second Notified Body for MDR

TÜV SÜD designated as second Notified Body for MDR

TÜV SÜD Product Service was designated by the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) as the second Notified Body for the EU Medical Devices Regulation (MDR).


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23.05.2019 | NEWS

PIC/S Meeting: What’s new for GMP?

PIC/S Meeting: What’s new for GMP?

In April 2019, the PIC/S Committee and the PIC/S Executive Bureau met in Geneva, Switzerland. The meeting was attended by 45 out of 52 PIC/S Participating Authorities as well as by a number of Applicants, Pre-Applicants, Associated Partners and Guests. Here are the topics addressed in the area of GMP:


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17.05.2019 | NEWS

EC confirms: Korean APIs in line with EU standards

EC confirms: Korean APIs in line with EU standards

On 14 May 2019, the European Commission confirmed that the quality of APIs produced in the Republic of Korea is in line with EU standards. APIs manufactured in third countries like the Republic of Korea, and intended for the EU market, have to be produced in an EU equivalent regulatory system. This includes the rules for GMP.


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14.05.2019 | NEWS

EMA Publishes Sterile Manufacturing Guidance

EMA Publishes Sterile Manufacturing Guidance

In March 2019, the European Medicines Agency (EMA) published the 25-page final version of the guideline "Sterilisation of the Medicinal Products, Active Substance, Excipient and Primary Container". The document will enter into force on 1 October 2019.


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07.05.2019 | NEWS

Q&A on Safety Features for Medicinal Products in Version 14

Q&A on Safety Features for Medicinal Products in Version 14

The European Commission published Version 14 of the Q&A document on Safety Features for Medicinal Products for Human Use at the beginning of this month. The document complements the Counterfeiting Directive 2011/62/EU and the Delegated Regulation (EU) 2016/161.


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03.05.2019 | NEWS

EU/US MRA on Inspections: Bulgaria and Cyprus accepted

EU/US MRA on Inspections: Bulgaria and Cyprus accepted

On 29 April 2019, the FDA has confirmed the capability, capacity and procedures in place of Bulgaria and Cyprus to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 24 EU member states, whose inspection results will be trusted in the future. This process is to be completed for all EU states by 15 July 2019.


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26.04.2019 | NEWS

Switzerland: Legal uncertainty for medical device manufacturers

Switzerland: Legal uncertainty for medical device manufacturers

In terms of the InstA (Institutional Agreement) between Switzerland and the EU, there is legal uncertainty. This directly impacts the entire medical technology industry in Switzerland, as it does not ensure an update of the MRA (Mutual Recognition Agreement) Switzerland/EU. Will the third country requirements of the MDR perhaps soon apply to Switzerland? And what has to be done to be prepared?


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17.04.2019 | NEWS

EU GMP Annex 1: When will the final version be released?

EU GMP Annex 1: When will the final version be released?

It has been and continues to be speculated when the final version of Annex 1 on the sterile manufacture of medicinal products will finally be published. At the beginning of this month, the issue was also discussed at the ISPE Annual Conference in Dublin. Dr. Sabine Paris from the editorial office of the GMP-Verlag was on site and brought these news with her:


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29.03.2019 | NEWS

EMA: Brexit-Q&A to the prevention of medicine shortages

EMA: Brexit-Q&A to the prevention of medicine shortages

EMA has published a 3-page questions-and-answers document (Q&A) on the work that the EU authorities are doing to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU.


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29.03.2019 | NEWS

ICH: New Inhalation-PDE for Cadmium in Q3D-Guideline

ICH: New Inhalation-PDE for Cadmium in Q3D-Guideline

On 22 March 2019, ICH published the final revision of the Guideline for Elemental Impurities Q3D (R1). The reason for the revision is an adjustment of the PDE value for cadmium by inhalation.


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15.03.2019 | NEWS

FDA: New Acting Commissioner Named

FDA: New Acting Commissioner Named

One week after the surprising resignation of FDA Commissioner Scott Gottlieb, Norman E. Sharpless, Director of the National Cancer Institute (NCI), was appointed Deputy Commissioner of the FDA, according to media reports.


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15.03.2019 | NEWS

MHRA: Six more documents on No-Deal Brexit

MHRA: Six more documents on No-Deal Brexit

Brexit - and no end in sight. In preparation for a "No-Deal-Scenario", the British Medicines and Health Products Regulatory Authority (MHRA) published six new guidelines on a "No-Deal-Brexit" - five on the import and export of medicines and active ingredients and one on paediatric studies.


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08.03.2019 | NEWS

FDA: CDER List for Planned Guidance Documents in 2019

FDA: CDER List for Planned Guidance Documents in 2019

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to release in 2019. A total of 93 planned guidance documents have been set out which are categorised in 15 different themes.


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08.03.2019 | NEWS

Brexit: News to Exemption for Batch Testing

Brexit: News to Exemption for Batch Testing

As already reported, Marketing Authorisation Holders (MAHs) who are unable to transfer their batch testing site from the UK to the EU27 by 29 March 2019 may be permitted, for a limited period of time, to rely on quality control testing performed in the UK under certain conditions.This exempting provision has now been officially included in the EMA practical guidance as the 31st question:

Can I request a delay for transfer of batch control testing to the EU/EEA?

Furthermore, the EMA provides a 3-page template to be used for submitting such requests to the EMA.


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01.03.2019 | NEWS

EMA publishes Q&A to MDR-/IVDR Compliance

EMA publishes Q&A to MDR-/IVDR Compliance

On 27 February 2019, the EMA published a question and answer document for the practical implementation of Regulation (EU) 2017/745 for medical devices (MDR) and Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).


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01.03.2019 | NEWS

Brexit and EU: Exemption for Batch Testing

Brexit and EU: Exemption for Batch Testing

With not even one month left until Brexit, the European Commission has sent a letter to the Director of the EMA (European Medicines Agency) and the EU27 Heads of Medicines Agencies to inform about an exemption to certain batch testing requirements for pharmaceutical manufacturers that perform their batch testing in the UK.


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22.02.2019 | NEWS

Swissmedic uses EU’s EudraGMDP database

Swissmedic uses EU’s EudraGMDP database

As reported by the European Medicines Agency EMA, the Swiss Agency Swissmedic, has started in 2019 to enter information on GMP compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP and should lead to easier information-sharing and efficiency gains for all stakeholders.


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22.02.2019 | NEWS

MHRA: Guidances on No-Deal-Brexit

MHRA: Guidances on No-Deal-Brexit

The British MHRA (Medicines and Healthcare Products Regulatory Agency) has launched a new website  containing all guidances and documents released for a no-Brexit-deal.


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15.02.2019 | NEWS

EU/US MRA on Inspections: Poland and Slovenia accepted

EU/US MRA on Inspections: Poland and Slovenia accepted

On 7 February 2019, the FDA has confirmed the capability, capacity and procedures in place of Poland and Slovenia to carry out GMP inspections at a level equivalent to the US. This concludes the FDA's assessment of a total of 22 EU member states, whose inspection results will be trusted in the future. This process is to be completed for all EU states by 15 July 2019. According to the EMA the plans for the agreement to come into operation in all EU Member States by 15 July 2019 are well on track. As Germany is still not officially recognised, the US FDA will continue to carry out its inspections there.


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01.02.2019 | NEWS

US-EU Trade Agreement: News for the GMP sector

US-EU Trade Agreement: News for the GMP sector

The Executive Working Group, EWG has published an interim report on the current status of its work. The focus is on the development of short- and medium-term practicable solutions in regulatory matters. In the area of pharmaceuticals and medical devices, the following approaches are being pursued or further pursued:


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01.02.2019 | NEWS

EMA: Brexit Preparedness Plan in Phase 4

EMA: Brexit Preparedness Plan in Phase 4

The relocation of the European Medicines Agency EMA to the Spark building in Amsterdam is proceeding according to plan. The move from London to Amsterdam should be completed by 1 March 2019. From 4 March, the EMA will then officially operate under a new address and the EMA staff will move into the new domicile in the week from 11 to 15 March.


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25.01.2019 | NEWS

PIC/S Work Plan 2019

PIC/S Work Plan 2019

At the beginning of the year, PIC/S published its annual work plan for 2019. In addition to organisational matters, a new group of experts on veterinary medicines will be set up and the training of inspectors will be further expanded. In the area of harmonisation, PIC/S is actively involved in the revision of the EU GMP guidelines.


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25.01.2019 | NEWS

Q&A to Safety Features in new Version 13

Q&A to Safety Features in new Version 13

In January 2019, the European Commission published a new version 13 of the Questions and Answers document on Safety Features for Medicinal Products for Human Use. Nine new questions were added and one question was revised.


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11.01.2019 | NEWS

ICH-Meeting in Charlotte, USA

ICH-Meeting in Charlotte, USA

The International Council for Harmonisation (ICH) met in Charlotte, USA, from 10 to 15 November 2018. The steadily increasing number of members (16) and observers (28) is an indication of the continuous development of the ICH into a global initiative. During the General Assembly, the Iranian authority NRA was welcomed as a new regulatory member.

 


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18.12.2018 | NEWS

ICH: Final Concept Paper to ICH Q13 „Continuous Manufacturing“

ICH: Final Concept Paper to ICH Q13 „Continuous Manufacturing“

The Management Committee of the ICH has endorsed the final concept paper and business plan on the new quality guideline ICH Q13 on continuous manufacturing for drug substances and drug products. Both documents are published on the ICH website.

 


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18.12.2018 | NEWS

ICH Q2/Q14: Final Concept Paper for Analytical Procedure Development

ICH Q2/Q14: Final Concept Paper for Analytical Procedure Development

The International Council for Harmonisation (ICH) has published the final concept paper for ICH Q14 (Analytical Procedure Development) on its website. In the course of the preparation of this new guideline, ICH Q2 (Validation of Analytical Procedures) will also be revised. It will be adapted to the state of the art to include modern analytical methods in the future. Both guidelines are intended to supplement the existing documents ICH Q8 - ICH Q12.

 


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14.12.2018 | NEWS

FDA Finalises Guidance on Data Integrity

FDA Finalises Guidance on Data Integrity

On 13 December 2018, the US FDA has announced the availability of the final guidance for industry “Data Integrity and Compliance with Drug CGMP: Questions and Answers.” The guidance updates a draft version released in 2016. It has been revised to include additional information on the agency’s current thinking on best practices and covers the design, operation and monitoring of systems and controls to maintain data integrity.


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07.12.2018 | NEWS

European Council Adopts Animals Medicines Package

European Council Adopts Animals Medicines Package

As stated in a European Council press release on 26 November, the Council of the EU adopted the "Veterinary Medicinal Products Package" with two new Regulations in the following areas:

  • veterinary medicinal products
  • the manufacture, placing on the market and use of medicated feed

and changes to the existing rules laying down procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.


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07.12.2018 | NEWS

PIC/S: Revised Draft Guidance for Data Integrity

PIC/S: Revised Draft Guidance for Data Integrity

On 30 November 2018, the PIC/S has published Draft No 3 of the “Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” (PI 041-1) for a focused stakeholder consultation.

 


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30.11.2018 | NEWS

New Version of Q&A to Safety Features for Medicinal Products

New Version of Q&A to Safety Features for Medicinal Products

The 28-page document setting out frequently asked Q&As regarding the implementation of the rules on the safety features for medicinal products for human use has been revised. As of November 2018, it is available in Version 12.

The changes compared to the superseded version regard questions 1.20 and 2.21:


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30.11.2018 | NEWS

MRA EU-US: Five Additional European Countries Named

MRA EU-US: Five Additional European Countries Named

On 16/28 November 2018, the US Food and Drug Administration (FDA) confirmed the capability of the following five additional EU Member States to carry out GMP inspections at a level equivalent to the United States:


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23.11.2018 | NEWS

EMA reports impurities in Valsartan from Mylan

EMA reports impurities in Valsartan from Mylan

On 19 November 2018, the EMA informed on their website that Valsartan from the Indian manufacturer Mylan Labortories is currently not allowed to be used for the production of medicinal products containing Valsartan for the EU. The CEP (Certificate of Suitability) of Mylan has been suspended by EDQM (European Directorate for the Quality of Medicines and Healthcare) because N-nitrodiethylamine (NDEA) has been found in some batches of valsartan.


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23.11.2018 | NEWS

EU and Health Canada plan to include GMP inspections on APIs in MRA

EU and Health Canada plan to include GMP inspections on APIs in MRA

The Comprehensive Economic and Trade Agreement (CETA) between the EU and Canada also includes the CETA GMP Protocol. In continuation of the MRA of 2003 between the EC and Health Canada this protocol also confirmed the  continued  mutual  recognition  of  GMP  inspections  and  batch  certification  between  EU  and  Canada  for  medicinal  products  for  human  use  and  veterinary medicines.


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16.11.2018 | NEWS

EMA: Draft Guideline on the Quality of Water for Pharmaceutical Use

EMA: Draft Guideline on the Quality of Water for Pharmaceutical Use

On 15 November 2018, the EMA has published a draft of the “Guideline on the Quality of Water for Pharmaceutical Use” for public consultation until 15 May 2019.

This 10-page document, once final, will replace the current “Note for guidance on quality of water for pharmaceutical use” from 2002 and the “CPMP Position Statement on the Quality of Water used in the production of vaccines for parenteral use".


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09.11.2018 | NEWS

EMA: Brexit Preparedness Plan Phase 3

EMA: Brexit Preparedness Plan Phase 3

The parallel preparing of the UK’s exit from the EU, the physical move to Amsterdam and operating “business as usual” as long as possible is the declared aim of the EMA. As of October 2018, EMA has launched Phase 3 of the “Brexit Prepardness Plan”, which results in additional temporary suspensions and scaling back of activities.


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09.11.2018 | NEWS

Australia and Canada expand their MRA

Australia and Canada expand their MRA

As of November 1, 2018 the Therapeutic Goods Administration (TGA) of Australia and Health Canada expanded their mutual recognition agreement (MRA) to cover active pharmaceutical ingredients (APIs).


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02.11.2018 | NEWS

PIC/S-Meeting 2018 in Chicago

PIC/S-Meeting 2018 in Chicago

The PIC/S Committee met on 24-25 September 2018, in Chicago. The meeting was attended by 38 Participating Authorities as well as by a number of Applicants, Pre-Applicants and Associated Partner Organisations. The event was hosted by the US FDA which symbolised the effort to strengthen inspectional approaches and assessments worldwide and to further share and discuss respective regulatory decisions and information. The keyword “harmonisation” and the impact of PIC/S on this matter had been especially highlighted by the FDA.


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26.10.2018 | NEWS

PANGEA XI: 500 Tonnes of Illegal Online Pharmaceuticals Seized

PANGEA XI: 500 Tonnes of Illegal Online Pharmaceuticals Seized

This year’s Operation PANGEA – an international effort to disrupt the online sale of fake and unlicensed health products around the world – took place from October 9 to 16, 2018. Starting with just eight countries in 2008, the operation has grown to 116 countries that participated this year.

 


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26.10.2018 | NEWS

ICH Q3C(R7) Published with Correction of PDE for Ethylenglycol

ICH Q3C(R7) Published with Correction of PDE for Ethylenglycol

As announced on the ICH website on October 25, the ICH Q3C(R7) Guideline along with Q3C Support Documents 1, 2, and 3 have now been published. The new R7-version of ICH Q3C is the result of an error correction of the Permitted Daily Exposure (PDE) for ethylenglycol as per the correct value calculated in Pharmeuropa, Vol. 9, No. 1, Supplement, April 1997 S36.


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19.10.2018 | NEWS

CDSCO: Draft of Indian Schedule M published

CDSCO: Draft of Indian Schedule M published

According to pharmabiz.com, the Indian regulatory authority CDSCO has published a draft version of the revised Schedule M. However, the document is currently only available in Indian language.


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12.10.2018 | NEWS

MHRA asks for comments on “No-deal” Brexit

MHRA asks for comments on “No-deal” Brexit

On October 4, the British MHRA (Medicines and Healthcare products Regulatory Agency) has launched a public consultation seeking views on how the agency’s legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no implementation period. This consultation covers no-deal proposals on medicines, clinical trials and medical devices.


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12.10.2018 | NEWS

FDA introduces cGMP Declarations

FDA introduces cGMP Declarations

On September 17, the US FDA announced a new online application, cGMP declarations. FDA's CDER will send ‘cGMP declarations’ to regulatory authorities in other countries where US firms want to market drug products.


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05.10.2018 | NEWS

CDRH publishes proposed Medical Device Guidance Development 2019

CDRH publishes proposed Medical Device Guidance Development 2019

On 3 October 2018, the US FDA’s Center for Devices and Radiological Health (CDRH) has published three lists of guidance documents that may be published in 2019:

 


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28.09.2018 | NEWS

CDRH works on blending ISO 13485 with 21 CFR 820

CDRH works on blending ISO 13485 with 21 CFR 820

We have already reported about the intention of the US FDA/CDRH to changing its quality system requirements for medical device manufacturers and utilise the International Organisation for Standardization (ISO) updated quality management standard, 13485:2016. Obviously the intention has already been put into action.


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21.09.2018 | NEWS

EU/US MRA on Inspections: Portugal accepted and Q&A updated

EU/US MRA on Inspections: Portugal accepted and Q&A updated

On 14 September 2018 the FDA has confirmed the capability, capacity and procedures in place of Portugal to carry out GMP inspections at a level equivalent to the US. There are now a total of 15 European Member States whose inspection results the FDA relies on to replace their own inspections.

 


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14.09.2018 | NEWS

Second Impurity Found in Valsartan

Second Impurity Found in Valsartan

Health Canada has identified a second impurity, N‑nitrosodiethylamine (NDEA) in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China. All drugs containing valsartan manufactured from that source have already been recalled in Canada after the first impurity, N-nitrosodimethylamine (NDMA), was identified earlier this summer. Both, NDEA and NDMA are classified as probable human carcinogens, which means that long-term exposure could cause cancer.


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07.09.2018 | NEWS

EMA: Tracking Tool for Relocation to Amsterdam

EMA: Tracking Tool for Relocation to Amsterdam

The EMA has published a tracking tool on its website, showing how things stand for the relocation to Amsterdam. It covers all aspects on EMA's temporary premises, its permanent premises, staff relocation, financial and legal aspects, removal and logistics and external communication.


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07.09.2018 | NEWS

FDA Publishes Internal Policy on Inspection Priorisation

FDA Publishes Internal Policy on Inspection Priorisation

On 5 September 2018, the US FDA has published a 7-page Manual of Policies and Procedures, MAPP, on how manufacturing facilities are prioritized and scheduled for surveillance inspections. This step should add greater transparency around the “Site Selection Model (SSM)”, used by CDER staff.


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31.08.2018 | NEWS

Six Asian Drug Manufacturers refuse FDA Inspection

Six Asian Drug Manufacturers refuse FDA Inspection

The US Food and Drug Administration, FDA, has added six Asian drug manufacturers to its import alert list this month, that refused a planned inspection of the FDA.


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31.08.2018 | NEWS

EU Task Force of EMA/HMA with New Programme on Medicine Shortages

EU Task Force of EMA/HMA with New Programme on Medicine Shortages

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have set up a task force with representatives from the European Commission, interested national competent authorities and other regulatory working groups. Their aim is to develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines.


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24.08.2018 | NEWS

UK Government Prepares for "No-deal Scenario" with EU

UK Government Prepares for "No-deal Scenario" with EU

Even though it is unlikely to happen, the UK government has got its plan B if, in any case, a no deal scenario for leaving the EU might materialise. Guidance thereto was published by the Department for Exiting the European Union on August 23, 2018.


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24.08.2018 | NEWS

Update on Medicines Containing Valsartan from Zhejiang Tianyu

Update on Medicines Containing Valsartan from Zhejiang Tianyu

Following the suspension of the CEP – a certificate verifying that the quality of its valsartan meets European requirements – for Zhejiang Huahai in July 2018, a second Chinese company Zhejiang Tianyu has now lost its authorisation to manufacture the valsartan active substance for EU medicines.


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