EU Annex 1 Revision
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.
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.