Last week’s round-up, 20-24 January 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


EMA Consults on GMP Reflection Paper

24 January 2020

The EMA has just released a draft reflection paper on good manufacturing practice (GMP) and marketing authorisation holders (MAHs), which is open for public consultation until 17th April 2020.

The paper focusses on clarifying the GMP responsibilities of MAHs. According to Annex 16 of the GMP guideline ‘the ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the MAH’. In cases where particular activities of an MAH are delegated to a manufacturer or other party, the GMP responsibilities still lie with the MAH.

Aspects of the Falsified Medicines Directive including safety features, European Hub-connected repositories, serialization data and decommissioning unique identifiers, are also discussed. However, some GMP requirements for ATMPs are not covered in the reflection paper.


European Regulatory Landscape 2020

23 January 2020

Our managing consultant, Michelle Gafa’, contributed the CMC perspective to this article on the European regulatory landscape for 2020.

(First published in the January issue of Regulatory Rapporteur.)


Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations

22 January 2020

The EMA has revised its ‘Q&A on impact of EU-USA Mutual Recognition Agreement (MRA) on marketing authorisation applications (MAAs) and relevant variations’ guidance.

The Q&A explains how MAAs and variations are affected by the EU-USA MRA and a link to further up-to-date guidance on the procedure is included. Applicants are encouraged to interact with regulators prior to filing an EU MA or variation application in order to discuss any potential inspections that may take place in the course of the procedure.

The provision in the EU-US MRA to accept the outcome of FDA inspections conducted outside the US is not yet operational.


EU NCAs to Offer Simultaneous Scientific Advice for Drug Developers

22 January 2020

From the 1st February 2020, twelve European national competent authorities (NCAs) will participate in a one-year pilot project to allow scientific advice to be given simultaneously by two NCAs. The project is part of an effort to better align scientific advice across the EU and increase the efficiency of the process.

The following NCAs will be participating in the pilot project: Austria (AGES), Belgium (FAHMP), Czech Republic (SUKL), Finland (FIMEA), Germany (PEI and BfArM), Hungary (OGYEI), Italy (AIFA), Norway (NOMA), Poland (URPL), Spain (AEMPS) and the UK (MHRA).


Soon to come: new Pharmeuropa website

20 January 2020

A new version of the Pharmeuropa website will be available on the 23rd January 2020 and current users will have to re-register to gain access. The current website will not be available during the change-over (22nd-23rd January).

The new platform will have some new features including single sign-on for users with access to the 10th Edition of the European Pharmacopoeia online.

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