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News about GMP/cGMP

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.

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The FDA issued a draft guidance outlining a framework of methods, designs and controls for preventing cross-contamination of non-penicillin beta-lactam antibacterial drugs and compounds,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 (Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability).

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.

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.

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).

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.

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.

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.

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).
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.

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.

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.

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.

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.

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:

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.

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.

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.

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.
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.

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.

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.

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."

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.

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.

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.

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.

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.

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. 

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.

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). 

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.
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.

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:

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.  

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.

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".
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.
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.

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.

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.

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).

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.

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.

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".

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.

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.

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
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).

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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