On 20 February 2020 the European Commission published the final draft of the EU GMP Annex 1. The previous draft had been published after a fundamental revision end of 2017. This draft contained many controversial new requirements. In 2017 the ECA set up a Task Force and provided feedback to EMA and the EU Commission. Please read more about the detailed comments on EU GMP Annex 1 prepared by the ECA Foundation.
The previous draft had resulted in more than 6,000 comments from different interest groups, companies and from individuals - a huge number and far beyond the expectation of the regulators. This is why the European Commission proceeds differently with the Final Draft of Annex 1. The European Commission only allows comments until 20 May 2020. In addition, the EU Commission only allows a small group of "targeted stakeholders" to prepare comments on the Final Draft EU GMP Annex 1 published on 20 February 2020.
The ECA Foundation and the European QP Association set up a Task Force to provide comments to the European Commission until 20 May 2020. The current Members of the Task Force are:
Chair: Dr Ingrid Walther, Independent Expert (Germany); Dr Friedrich Haefele, formerly Boehringer Ingelheim (Germany); Alexandra Staerk, Novartis Basle (Switzerland); Dr Tilmann Rock, Roche Mannheim (Germany); Arjan Langen, MSD (The Netherlands); Stephan Loew, CSL Marburg (Germany); Walid El Azab, Steris (Belgium); Dr Jean-Denis Mallet, NNE Pharmaplan (France); Dr Bernd Renger, Independent Expert (Germany); Ralf Holzinger, B. Braun Melsungen (Germany) and Dr Thomas Schreiner, Fresenius (Germany).
The joint ECA and European QP Association Task Force has already started with the detailed evaluation. It is also planned to prepare a survey to ask all ECA Academy Members as well as European QP Association Members in order to collect feedback and thus to support the comments prepared. Please follow the ECA and European QP Associations announcements on their websites.
In addition, the ECA decided to offer some first insights and analyses about the content of the Final Draft EU GMP Annex 1. The following articles have already been published (list will be updated regularly):
It is important to emphasize that the EU GMP Annex 1 will become a worldwide standard. In addition to the EU Commission, also the PIC/S and the WHO have published the same draft document. It will be interesting to see how US FDA will react on the new document. The US FDA is also member at PIC/S. So far the FDA has not published any information with regard to their future expectations. However, the current US FDA requirements defined in the FDA Guidance for Industry - Sterile Drug Products Produced By Aseptic Processing are already more than 15 years old.
If you wish to receive the latest updates about proposed changes to EU GMP Annex 1 we recommend to register for the ECA and European QP Association EU GMP Annex 1 Conference which is scheduled to take place from 3-4 July 2020 in Berlin.