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News about GMP/cGMP

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. 

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.  

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

PICS/S: Four Aide-Mémoires updated

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

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.

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.

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.

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.

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. 

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.

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.


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.


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. 


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.


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.


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. 


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.


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.  


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


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.


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).


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.  


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.


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.


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


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.


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.


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.


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.


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.  

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. 


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.


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.


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.


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.


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.


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: 


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. 


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:


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.


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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