Skip To The Main Content
Biopharmaceuticals and Biotechnology

EU Annex 1 Revision

The Current EU GMP Annex 1, Manufacture of Sterile Medicinal Products, is under revision by the EMA Inspector Working Group. The latest revision draft (version 12) has expanded the annex from 16 to over 50 pages and includes new requirements as well as additional detail related to many of the requirements presented in the current version of Annex 1. PDA has and continues to be very involved on this topic.

EU GMP Annex 1 Revision Draft (version 12)

PDA Commenting Team on the EU GMP Annex 1 Revision

In July of the 2020, PDA submitted comments to the EMA on the Annex 1 draft (version 12). The comments were developed by an active PDA Commenting Team comprised of experts in the field of aseptic processing.

PDA Comments to EMA on EU GMP Annex 1 Revision 13 July 2020

Cross-Association Coordination Group on EU GMP Annex 1 Revision

PDA is also part of a Cross-Association Coordination Group which includes A3P, AnimalhealthEurope, AESGP, ECA, EFPIA, EIPG, EQPA, ISPE, Medicines for Europe, PDA, PHSS, and Vaccines Europe. This group meets to discuss the Annex 1 revision and has developed Joint letters on areas where there is shared positions amongst all the associations. Two letters have been developed to date.

Implementation Examples - EU GMP Annex 1 Draft (version 12) - 25 May 2021