EU GMP Annex 1: When will the final version be released?
It has been and continues to be speculated when the final version of Annex 1 on the sterile manufacture of medicinal products will finally be published. At the beginning of this month, the issue was also discussed at the ISPE Annual Conference in Dublin. Dr. Sabine Paris from the editorial office of the GMP-Verlag was on site and brought these news with her:
In short: The publication of the final Annex 1 may be delayed until early autumn. There are several reasons for this:
- Andrew Hopkins, Expert GMDP Inspector and Chairman of the EMA/PIC/S Annex 1 Working Group, left the MHRA in December 2018.
- The GMP/GDP Inspectors Working Group (IWG) has now "moved" to Amsterdam, which has led to further work delays. Due to the relocation of the EMA to Amsterdam, all EMA activities will be severely restricted until June 2019. For example, no on-site meetings of the various working groups will take place until at least September 2019. Brexit plays an important role here.
- For Annex 1, 6200 comments were received from 140 different contributors.
So we just have to keep practicing patience!
MHRA: Note of Meeting, GMP/GDP Consultative Committee