Annex 1 Revision - what is the current status?

In 2017, the first draft revision of Annex 1 of the EU GMP Guideline was published and the public consultation resulted in over 6000 comments. After detailed editing, a second draft was published in February 2020. In order to avoid unnecessary repetition of comments that had already been submitted and rejected in the first commenting phase, the European Commission had this time resorted to the so-called "stakeholder consultation". This means that only selected organizations and interest groups may submit comments. The Commission also determined which sections of the new draft still needed to be commented on and defined a small scope for important further comments. The ECA and the European QP Association (EQPA) also took part in this commentary (see news of 06.05.2020).

But what are the next steps?

The timeframe until the release of a final version cannot be predicted exactly at present. According to unofficial information, approximately 2000 comments have been submitted for the second commentary, so that the responsible members of the expert group will need some time to examine them and decide on their acceptance or rejection

The ECA Live Online Annex 1 Conference on 10/11 November 2020, where representatives of the supervisory authorities, industry and members of the Annex 1 Task Force will discuss the possible consequences of the revision and the extent to which individual companies are already implementing the expected requirements, will take place.

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