GMP:Blog

 

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12.04.2024 | NEWS

EU: Parliament Adopts Position on EU Pharmaceutical Reform

On 10 April, the EU Parliament approved a legislative package to reform the EU‘s pharmaceutical legislation, with the aim of boosting innovation and improving the accessibility and affordability of medicines. The package, which includes a new directive and a regulation, recieved strong support from Members of the European Parliament (MEPs).


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12.04.2024 | NEWS

EDQM: European and Japanese Pharmacopeias Launch Harmonisation Project

The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are launching a joint project to harmonise pharmacopoeial standards for active substances and medicinal products. This initiative aims to reduce the burden on manufacturers by aligning pharmacopoeial standards across different regulatory regions.


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03.04.2024 | NEWS

PMDA: English Version of Biosimilar Q&As

On 27 March 2024, Japan's PMDA (Pharmaceuticals and Medical Devices Agency) published an English-language version of its updated recommendations on the quality, safety, and efficacy of biosimilars. The 14-page document, Questions and Answers on Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars, has been updated to reflect the current state of scientific knowledge. The revised sections of the document are indicated and relate to Q&As 9, 10, and 11.


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27.03.2024 | NEWS

Nitrosamines: EMA updates Appendix 3 of the Q&A

Appendix 3 of the EMA’s Nitrosamine Q&A has been updated. The Appendix deals with the enhanced Ames test conditions for N-nitrosamines.


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25.03.2024 | NEWS

German Cannabis Law Comes into Force on 1 April

On 22 March, the German Cannabis Law was passed by the Bundesrat. The law will therefore come into force on 1 April as planned.


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15.03.2024 | NEWS

EC: Harmonised Standards for Medical Device Sterilisation

The European Commission adopted two implementing decisions on the sterilisation of medical devices. These decisions were made in accordance with the regulations governing medical devices and in vitro diagnostics (IVDs) in the EU.


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08.03.2024 | NEWS

ECJ: European Standards Should be Freely Accessible

The European Court of Justice (ECJ) has ruled that harmonised technical standards are part of EU law and should therefore be freely accessible to EU citizens (Judgment of 05.03.2024, ref. C-588/21 P).


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05.03.2024 | NEWS

Cannabis GMP Wiki planned

Are you involved in the production of medicinal Cannabis? Then the Cannabis GMP Wiki is of interest to you.


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29.02.2024 | NEWS

EMA: 14 New/Updated Acceptable Intakes for N-nitrosamines

An update of the EMA's Appendix 1 to the questions and answers for marketing authorisation holders/applicants on nitrosamine impurities in human medicinal products has just been published (EMA/72902/2024 /Rev. 3).


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26.02.2024 | NEWS

German Bundestag Passes Cannabis Law

On 23 February, the German Bundestag approved the government's bill on the "controlled use of cannabis". The law allows adults to possess up to 50 grams of cannabis in private and up to 25 grams in public.


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22.02.2024 | NEWS

ICH: ICH Q12 Module 8 Training Material is Available

The ICH Q12 Implementation Working Group (IWG) "Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management" Module 8 Training Material is now accessible on the ICH website.


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22.02.2024 | NEWS

ICH: Revision 9 of ICH Q3C Guideline Finalised

The ICH Q3C “Guideline for Residual Solvents” has undergone revision to become finalised as version R9 using the Minor Revision Procedure. This revised document was published on 24 January 2024 and reached Step 4 of the ICH Process, which is the adoption of a harmonised guideline.


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19.02.2024 | NEWS

EDQM: TOP 10 Deficiencies in New CEP Applications

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the top 10 deficiencies identified in 2023 following the initial evaluation of new applications for Certificates of Suitability (CEP).


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09.02.2024 | NEWS

MHRA: Designation of Two New UK Approved Bodies

On 31 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the designation of two new UK Approved Bodies (UKAB) to increase the capacity to certify the performance and safety of medical devices.


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09.02.2024 | NEWS

WHO: New Edition of the GMP Compendium for Medical Products

The World Health Organization (WHO) has published the 10th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volume 2, Good manufacturing practices (GMP) and inspection".


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07.02.2024 | NEWS

FDA: Medical Devices – Quality System Regulation Amendments

The US Food and Drug Administration (FDA) has released its Quality Management System Regulation (QMSR) final rule after years of development. It is a rework of the Quality System Regulation (QSR) – 21 CFR Part 820.


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02.02.2024 | NEWS

Swissmedic: Risk Assessment for Nitrosamine Drug Substance-Related Impurities (NDSRI)

Swissmedic has further specified risk assessment measures for Nitrosamine Drug Substance-Related Impurities (NDSRI). Initially identified in 2018, nitrosamine impurities, including those in antihypertensives, prompted ongoing evaluations and measures by Swissmedic to prevent such impurities.


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26.01.2024 | NEWS

India: Health Ministry Revised Schedule M for GMP

The Indian Health Ministry has introduced revised rules under Schedule M of the Drugs and Cosmetics Rules, aimed at ensuring robust quality control for pharmaceutical and biopharmaceutical products. Schedule M outlines Good Manufacturing Practices (GMP) for pharmaceutical products.


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26.01.2024 | NEWS

EDQM: Confidentiality and Declassification of CEP Documents

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has elaborated a document describing the principles for the declassification of documents pertaining to the CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) procedure while ensuring when necessary, the confidentiality of information.


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22.01.2024 | NEWS

Swissmedic: Invalid Certification of the Notified Body ECM

On 9 January 2024, the Swiss Medicines Agency Swissmedic informed about critical deficits in the system of medical device regulation. 


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19.01.2024 | NEWS

EMA: 3 new Q&As on EU GMP Annex 1

The EMA has published 3 new or updated questions and answers on Annex 1 of the EU GMP Guide. They deal with bioburden levels and sampling, and open versus closed isolators. The answers are summarised below:


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19.01.2024 | NEWS

EMA: 7 Q&As on In-use Shelf Life of Sterile Products After Opening/Reconstitution

The European Medicines Agency (EMA) has added 7 Q&As to their quality of medicines questions and answers. They refer to EMA‘s 1998 guidance on the shelf-life of sterile products for human use after opening or reconstitution (CPMP/QWP/159/96 corr).


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12.01.2024 | NEWS

EMA: Q&A on Brexit Rules for Centrally Authorized Medicinal Products in Northern Ireland

The European Medicines Agency (EMA) has answered nine questions on the application of revised Brexit rules to centrally authorised medicinal products for human use in Northern Ireland (Regulation (EU) 2023/1182).


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08.01.2024 | NEWS

EDQM: Ph. Eur. Reference Standards for Cannabis Flowers now Available

The EDQM informs that the standards cannabis flower for system suitability HRS (Herbal Reference Standard) and cannabidiol for cannabis CRS (Chemical Reference Substance) that are described in the newly adopted monograph on Cannabis flower (3028) are now available for users under catalogue code Y0002440 and Y0002422 respectively.


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17.12.2023 | NEWS

MHRA: Alignment With EU on Extention of GMP and GDP Certificates

On 11 December, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) announced a validity extension of GMP and GDP certificates.


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15.12.2023 | NEWS

EMA: Validity of GMP and GDP Certificates in 2024

On 7 December 2023, the European Medicines Agency (EMA) published an important update on the validity of GMP certificates after COVID-19 on its Good Manufacturing Practice website:

The validity of GMP and GDP certificates, which were automatically extended to the end of 2023 under COVID-19, will be extended until 2024. Either the validity date until 2024 or the conclusion of the next on-site inspection applies, whichever comes first unless stated otherwise in the relevant document. The working group of GMP/GDP inspectors decided to continue the extension.


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15.12.2023 | NEWS

European Commission: EU Reference Laboratories Designated for IVDs

On 5 December 2023, the European Commission (EC) announced that it has adopted an implementing act to designate five EU reference laboratories (EURLs) for class D in vitro diagnostic medical devices (IVDs).


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12.12.2023 | NEWS

EDQM: Ph. Eur. Pre-publishes Revised Propylene Glycol Monograph

The EDQM pre-published the revised monograph on Propylene glycol (0430) adopted by the European Pharmacopoeia Commission (EPC) at its 177th session held on 21 and 22 November 2023. The revision took part as a response to the public health risk posed by the discovery of ethylene glycol (EG) and diethylene glycol (DEG) contamination in several medicinal products in Africa and Asia and confirmed cases of propylene glycol adulterated with EG with over 190 fatalities in Indonesia.


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08.12.2023 | NEWS

EMA: Q&A on Use of X-Ray Sterilisation

On 9 November 2023, the EMA published a 5-page document with three Q&As on the extended interpretation of Annex 12 of the EU GMP Guideline "Manufacture of medicinal products using ionising radiation" for X-ray sterilisation processes. The questions relate to the use of X-ray sterilisation for single-use systems (SUS) in pharmaceutical manufacturing. These processes are becoming increasingly established.


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04.12.2023 | NEWS

Latest News from PIC/S

From 6 to 7 November 2023, the PIC/S Committee Meeting took place in Bangkok, Thailand, chaired by Paul Gustafson from Health Canada. The Ministry of Public Health of the Thai Food and Drug Administration (Thai FDA) hosted the meeting.

The meeting was attended by 37 of the 56 Participating Authorities (PAs) as well as various applicants, pre-applicants and partner organisations.


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24.11.2023 | NEWS

Swissmedic: Technical Interpretation on Annex 1 Published

On 31 October 2023, Swissmedic published a Q&A with the title "Interpretation of GMP Annex 1 2022 (Rev. 1)". In the 25-page document, the Swiss Agency for Therapeutic Products provides key answers to questions related to Annex 1, which came into force in August 2023, and to repeatedly asked questions from the previous version.


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17.11.2023 | NEWS

ICH: Q5A(R2) Guideline on Viral Safety of Biotechnology Products adopted

The Assembly of the International Council for Harmonisation (ICH) has adopted the revised Q5A(R2) Guideline on the Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The guideline describes a general approach to testing and assessing the viral safety of those products and sets out the data that should be submitted in marketing authorisation applications and registration packages. These products include biotherapeutics and biological products derived from characterised cell cultures of human or animal origin (mammals, birds, insects). The term "virus" used therein does not include non-conventionally transmissible pathogens, such as mammalian prion-associated pathogens.


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17.11.2023 | NEWS

EMA: Update of Q&A on Nitrosamine Impurities

After only ten days, the European Medicines Agency (EMA) published yet another revised version of the Q&A on nitrosamine impurities for marketing authorisation holders on 12 October 2023. With revision 19, Annexes 2 and 3, among others, were removed from the document and are now available as separate Appendices.


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17.11.2023 | NEWS

MedTech Europe: Vision for MDR/IVDR Reform

On 7 November 2023, MedTech Europe published a position paper on the Medical Devices Regulation (MDR (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR (EU) 2017/746). In the report, the association presents its vision for a regulated legal framework and outlines possible solutions to the ongoing challenges, which have not been overcome after the implementation phase of the MDR and IVDR.


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14.11.2023 | NEWS

WHO: Recognition for Swissmedic and two other authorities

On 30 October 2023, the World Health Organization (WHO) recognized regulatory authorities as "WHO-Listed Authorities" for the first time. WHO-Listed Authorities (WLA) are regulatory authorities that operate in accordance with international standards and fulfil the requirements based on an established benchmarking and performance evaluation process.


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10.11.2023 | NEWS

ICH: Parallel Guidances Q2(R2)/Q14 on Analytical Procedures adopted

The Assembly of the International Council for Harmonisation (ICH) adopted the revised Q2(R2) Guideline on the Validation of Analytical Procedures and the new Q14 Guideline on Analytical Procedure Development. 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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03.11.2023 | NEWS

MHRA: Regulatory ‘Sandbox’ for AI Developers

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it is planning to establish a new AI-based "regulatory sandbox" to help artificial intelligence (AI) developers test and provide evidence for their technologies in a virtual space under regulatory monitoring. The so-called AI-Airlock is expected to go into operation in April 2024.


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03.11.2023 | NEWS

Operation Pangea XVI: Global Illicit Medicines Targeted by INTERPOL Operation

Every year since 2008, the International Criminal Police Organisation (INTERPOL) has carried out large-scale operations to combat the illegal trade in medicines, known as Operation Pangea.


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27.10.2023 | NEWS

European Commission: Steps to Ensure the Availability of Medicines

On 24 October 2023, the European Commission adopted steps to prevent drug shortages and increase the security of supply in the European Union.


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27.10.2023 | NEWS

Submit IVDR Applications for Class D Devices Before the End of 2023

Team-NB, the European association of Notified Bodies, strongly recommends that medical device manufacturers of Class D devices submit applications for In Vitro Diagnostic Regulation (IVDR) certification this year to ensure timely processing.


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23.10.2023 | NEWS

ICH: Training materials for the Q9(R1) Guideline

In October 2023, the International Council for Harmonisation (ICH) published training materials to complement the revised Q9(R1) guideline on quality risk management.


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20.10.2023 | NEWS

EDQM: Ph. Eur. Pre-Publishes Cannabis Flower Monograph

The new monograph on Cannabis flower (3028) will be published in Ph. Eur. Supplement 11.5 in January 2024. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information.


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13.10.2023 | NEWS

New cleanroom standard for particle sampling

A new part of the ISO 14644 cleanroom series has been published: ISO/TR 14644-21:2023 Cleanrooms and associated controlled environments — Part 21: Airborne particle sampling techniques.


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06.10.2023 | NEWS

EMA: Q&A on Nitrosamines Updated to Rev. 18

The EMA Q&A on nitrosamine impurities has been updated on 2 October 2023 and is now available as Revision 18. The update concerns Q&A 3 regarding the “call of review” and how to report steps 1 and 2 to the competent authorities. The update highlights the responsibilities of MAH(s) to control, report, and mitigate the detection of Nitrosamine impurities throughout the product life cycle, using the established procedure.


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06.10.2023 | NEWS

Swissmedic: FAQ on Pharmacovigilance Updated

On 25 September 2023, Swissmedic expanded a list of frequently asked questions for marketing authorisation holders submitting adverse drug reaction (ADR) reports under the authority's pharmacovigilance program. The Swiss surveillance authority is thereby preparing manufacturers in its area of application for the additional documentation requirements in individual case reports, which will be mandatory from 1 January 2024.


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22.09.2023 | NEWS

MedTech: Call for Structural Reform of MDR and IVDR

MedTech Europe, along with 34 national associations, published an open letter to EU Health Commissioner Stella Kyriakides on 14 September 2023.


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22.09.2023 | NEWS

EMA: Q&A on Biological Medicinal Products

The EMA has published 14 questions and answers for biological products on its website. The CHMP Biologics Working Party developed the page that provides their agreed positions on issues that typically arise from discussions or correspondence during assessment procedures of biological human medicinal products.


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15.09.2023 | NEWS

WHO: Draft on Good Practices for Pharmaceutical Quality Control Laboratories

The WHO has recently published a draft document that will be of interest to all GMP practitioners in the field of pharmaceutical quality control laboratories: WHO good practices for pharmaceutical quality control laboratories. It provides recommendations for a Quality Management System (QMS) within which analyses of pharmaceutical products should be performed by quality control laboratories. The aim is to ensure accurate and reliable analytical results.


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15.09.2023 | NEWS

Swissmedic: Swiss GMDP database in early 2024

According to Swissmedic, the independent SwissGMDP database will be launched in the first quarter of 2024. The database will be maintained similar to the European EudraGMDP database of the EMA. The GMP or GDP certificates of every company in Switzerland that has a valid Swissmedic operating licence will be listed. Contrary to the EudraGMDP, the SwissGMDP certificates contain all approved activities, i.e. the GDP activities and Switzerland-specific GMP activities of the Swiss companies will also be listed in the certificates.


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28.08.2023 | NEWS

Swissmedic: GMP/GDP inspections accreditation for ATMPs

On 9 August 2023, Swissmedic announced its accreditation for GMP/GDP inspections in the field of ATMPs (Advanced Therapy Medicinal Products). Previously, the authority's competence confirmation was limited to medicinal products.


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25.08.2023 | NEWS

EMA: Q&A on Nitrosamines Updated to Rev. 17

To a new one! The EMA Q&A on nitrosamine impurities has been updated again after only three weeks and is now available as Revision 17 corr. The update concerns Q&As 20, 21 and 22 and a correction of the table including the potency score calculation in example 4 for N-nitroso-l-nebivolol. It had been omitted in the previously revised version 17 and has now been re-introduced.


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25.08.2023 | NEWS

MHRA: Independent Regulation of CE Marking of Medical Devices

On 1 August 2023, the UK government published a statement on the indefinite extension of CE marking recognition beyond 2024. MHRA clarifies: This extension does not apply to medical devices and in vitro diagnostic medical devices.


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24.08.2023 | NEWS

FDA: Guidance on Substance-related Nitrosamine Risks

This month the US FDA issued a 28-page new guidance for immediate implementation, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). It provides drug manufacturers and applicants with a framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA. Ways to predict the mutagenic and carcinogenic risk of NDSRIs and acceptable intake (AI) limits are outlined.


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18.08.2023 | NEWS

PIC/S: Revision of GMP Guide includes new EU Annex 1

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has again revised its GMP Guide. Changes have been made to include the new EU Annex 1 on Sterile Manufacturing of Medicinal Products, which enters into force on Friday, 25 August 2023. From this same date, the PIC/S GMP Guide will also be valid.


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04.08.2023 | NEWS

MHRA: Guidance on Labelling/Packaging of Medicinal Products

The UK MHRA has released guidance on the labelling and packaging of medicinal products following the Windsor Framework. It introduces a “UK Only” label and the take over of the MHRA to approve and license medicines across the UK. Furthermore, the application of the EU Falsified Medicines Directive (FMD) in Northern Ireland will no longer apply. The Windsor Framework covers the supply of medicines into Northern Ireland and will replace the current Brexit conditions.


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28.07.2023 | NEWS

Swissmedic: Mutual Recognition Agreement with US FDA in Force

The Mutual Recognition Agreement between Switzerland and the USA signed in January entered into force on 27 July 2023. As already reported, the MRA allows the FDA and the Swissmedic to share and use each other's GMP inspectional findings regarding medicinal products.


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28.07.2023 | NEWS

EC: Updated Q&A on MDR and IVDR

The European Commission updated the Q&A document on the new transitional provisions for certain medical devices and in vitro medical devices with five additional questions on 18 July 2023.


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24.07.2023 | NEWS

EMA: Q&A on Remote Batch Certification and QP Residency

The European Medicines Agency (EMA) has published four new questions and answers around Remote Batch Certification/Confirmation of a Qualified Person (QP). One Q&A deals with the residence specification for a QP. They apply to EU/EEA QP certification or QP confirmation, as described in EU GMP, and specifically in Annex 16. It applies to the manufacture and importation of human and veterinary medicinal products and investigational medicinal products.


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21.07.2023 | NEWS

EMA: Update Q&A "Centralised Procedures"

In late June 2023, the European Medicines Agency updated two Q&A documents on centralised marketing authorization procedures. With this, EMA provides scientific and regulatory advice to pharmaceutical companies on the regulatory process for the European drug approval. Q&As relevant before, during, and after the approval of medicines for the European market have been updated or newly added.


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17.07.2023 | NEWS

EMA: Expiration of Extraordinary COVID-19 Regulatory Flexibility

On 6 July 2023, the European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) announced that they were phasing out the extraordinary regulatory flexibilities for medicines that were effective during the COVID-19 pandemic.


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14.07.2023 | NEWS

EMA: Q&A on Nitrosamines Updated

The EMA has updated its Q&A document on N-nitrosamines as of 7 July 2023. Revision 16 comes with an amendment to Q&A 10 on the limits that apply for N-nitrosamines in medicinal products. Introduced are the Carcinogenic Potency Categorization Approach (CPCA) and the enhanced Ames test (EAT) for establishing acceptable intakes (AIs) for N-nitrosamines.


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07.07.2023 | NEWS

FDA/CDER: Revised MAPP on cGMP Surveillance Inspections

The US FDA’s CDER revised the Manual of Policies and Procedures (MAPP) on managing surveillance inspections based on its Site Selection Model. The CDER staff uses this model to prioritise manufacturing sites for national and international routine quality-related cGMP surveillance inspections.


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06.07.2023 | NEWS

Swissmedic: Specialist Group for Nitrosamine Issues

On 1 July 2023, the new "Nitrosamines Specialist Group" of the Swiss regulatory agency Swissmedic started its work, as announced in May. The group is divided into a coordination office and a centre of expertise for all issues regarding nitrosamines.


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27.06.2023 | NEWS

ICH: Press Release ICH-Assembly Meeting

The ICH published a press release on June 20, regarding a face-to-face meeting on June 12 and 13, 2023, in Vancouver, Canada. Meetings of 14 working groups, the ICH Management Committee and the MedDRA Management Committee were also held during that time.


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22.06.2023 | NEWS

TGA: Regulatory requirements for medical devices

The Australian Therapeutic Goods Administration (TGA) has opened a consultation on 16 June 2023 on the risk classification of medical devices containing certain animal, microbial or recombinant materials.


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09.06.2023 | NEWS

MHRA: New Recognition Routes with Seven Regulatory Partners

The MHRA is further extending its regulatory network. A new regulatory recognition framework for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. It should be in place by the first quarter of 2024.


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02.06.2023 | NEWS

EC: Template for Notified Bodies

On 24 May 2023, the European Commission provided a downloadable template that notified bodies can use under Regulation (EU) 2023/607.


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02.06.2023 | NEWS

EMA: EU – US Mutual Recognition Agreement for Veterinary Medicines Inspections

The mutual recognition of inspections of certain veterinary medicines between the European Union and the United States has reached a significant milestone: On 31 May 2023, the US FDA recognised the capability of 16 EU Member States to carry out GMP inspections for certain veterinary products at a level equal to the US. At the same time, the EU also recognised the FDA as an equivalent authority for GMP inspections of sites manufacturing veterinary medicines.


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01.06.2023 | NEWS

Now available: Chapter on Contamination Control Strategy in the GMP Compliance Adviser

In the context of the revised Annex 1 (we reported), the Contamination Control Strategy (CCS) is currently an issue everyone is talking about. This concept must be implemented by 25 August 2023 – when Annex 1 comes into force.


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26.05.2023 | NEWS

EDQM: 21st Edition of the Blood Guide Published

The European Directorate for the Quality of Medicines & HealthCare (EDQM) published the 21st edition of the Guideline for the Preparation, Use, and Quality Assurance of Blood Components earlier this month. As a compendium of widely accepted, harmonised European technical standards the guide should provide safety, efficacy, and quality requirements for the preparation, use, and quality control of blood components in Europe and beyond.


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26.05.2023 | NEWS

UK and Switzerland Negotiate New Trade Arrangement

According to a press release from the UK government Switzerland and the United Kingdom have started negotiations on a modern and free trade arrangement (FTA) this month.


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26.05.2023 | NEWS

EMA: Annual Report 2022 Published and Workplan for GMDP Updated

As part of the recent publication of EMA's Annual Report 2022, the 3-year work plan 2021-2023 has also been updated. The 13-page work plan has been developed with a main focus on the network strategy and the scientific regulatory strategy (RSS). The security and resilience of the supply chain is of particular importance.


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19.05.2023 | NEWS

EMA: Guidance for Industry to Prevent Medicine Shortages

On 17 May 2023, EMA published recommendations for industry on the good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. The 14-page guidance describes the various stakeholders involved in the medicine supply chain and their responsibilities and roles in the prevention and management of medicine shortages. It provides ten recommendations for marketing authorisation holders, wholesalers, distributors, and manufacturers to minimise the occurrence of medicine shortages and their impact.


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05.05.2023 | NEWS

Swissmedic: Guidance on GMP-Compliance by Foreign Manufacturers and RP Declaration

The Swissmedic Guideline on GMP-Compliance by Foreign Manufacturers was published on 1.5.2023 as version 3.0. It is addressed to the holders of marketing authorisations for medicinal products from abroad or from Switzerland if these medicinal products contain active substances from foreign manufacturers.


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05.05.2023 | NEWS

EU: Proposal on Reform of Pharmaceutical Legislation

On 26 April 2023, the European Commission published a 182-page proposal for the reform of the EU's pharmaceutical legislation and a 184-page proposal for the repeal of Directives 2001/83/EC and 2009/35/EC with a 103-page Annex. The proposal should pave the way for the biggest reform in more than 20 years and aims to reshape the regulation of the pharmaceutical sector.


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28.04.2023 | NEWS

EMA: Multi-factor Authentication for CTIS Mandatory by June

From 1 June 2023 multi-factor authentication (MFA) will be introduced for user login to CTIS (Clinical Trials Information System) for both sponsors and Member States. This should significantly increase user account security.


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14.04.2023 | NEWS

WHO: Draft on Revised GMP for Excipients in Pharmaceutical Products

This week the WHO published a draft guideline on GMP for excipients used in pharmaceutical products. With the original guideline published in 1999, a revision was overdue. Excipients play an essential role in pharmaceutical dosage forms and their impact on the quality of the finished product is considerable. The guideline is addressed to excipient manufacturers and pharmaceutical manufacturers.


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14.04.2023 | NEWS

EMA: GCP-Guideline on Computerised Systems and Data Integrity

Last month, the EMA published the final guideline on computerised systems and data integrity in clinical trials, which will enter into force on 10 September 2023. Clinical trials are increasingly using computerised systems for data collection, which come with progressively more complex user surfaces.


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06.04.2023 | NEWS

EMA: Q&A on Nitrosamines Updated

The European Medicines Agency EMA updated its Q&A on nitrosamines on 30 March 2023. The update amends Q&A 22 referring to the approach to control  the presence of nitrosamines exceeding the AI during CAPA implementation. It is now indicated that no variation should be submitted to implement temporary above AI (acceptable intake) limits in specifications.


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06.04.2023 | NEWS

Swissmedic: Equivalence with New EU MDR/IVDR Timelines

The Swiss Federal Council intends to grant an extended period for the certification of medical devices in accordance with the extension of the corresponding EU regulation (we reported). This will require an amendment of the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). The revision of the two ordinances is planned for autumn 2023.


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03.04.2023 | NEWS

ICH: Publication of the Introductory Presentation on ICH Q9 (R1)

The ICH published a 29-page presentation on the revision of ICH Q9 on 14 March 2023. The guideline on quality risk management was published in January 2023 (we reported) and will come into force in July 2023.


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31.03.2023 | NEWS

EU: Q&A on extended MDR transition

The European Commission has released a 10-page Q&A document on the practical aspects of the new transitional provisions for certain medical devices and iv-medical devices. These were laid down in the Regulation (EU) 2023/607, which was published on 15 March 2023 (we reported).


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24.03.2023 | NEWS

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

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

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

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

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

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

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 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

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 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

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

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

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

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: 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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13.01.2023 | NEWS

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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19.12.2022 | NEWS

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'

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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29.07.2022 | NEWS

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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22.07.2022 | NEWS

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

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

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

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

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

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?

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

 

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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.

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 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

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

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

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

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

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

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

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

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

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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04.02.2022 | NEWS

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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28.01.2022 | NEWS

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

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

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

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

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

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

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

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

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

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

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

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

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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19.11.2021 | NEWS

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

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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12.11.2021 | NEWS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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

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

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

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 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

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

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

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

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 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

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

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

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

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.

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

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

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

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

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

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

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 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

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

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

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

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

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 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

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

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

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

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

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 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

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

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

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

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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25.02.2021 | NEWS

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

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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19.02.2021 | NEWS

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

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 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

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

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

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

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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28.01.2021 | NEWS

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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22.01.2021 | NEWS

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

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

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

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

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

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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14.01.2021 | NEWS

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

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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21.12.2020 | NEWS

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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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23.10.2020 | NEWS

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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16.10.2020 | NEWS

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

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

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

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

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

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

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

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

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

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

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

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

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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14.08.2020 | NEWS

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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07.08.2020 | NEWS

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

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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24.04.2020 | NEWS

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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17.04.2020 | NEWS

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

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

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

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

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

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

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.