News about GMP/cGMP

17.04.2019

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!


Source:

MHRA: Note of Meeting, GMP/GDP Consultative Committee



Comments

10 days ago, a HPRA representative at the PDA Ireland's Annex 1 event informed the audience that the IWG will have a telephone conference in June at which they could agree to adopt the current version of Annex 1. If they do so, this will then be sent to the European Commission for their review and ultimate adoption. The new rapporteur for Annex 1 is the French agency. Given that timeframe, the very earliest, Annex 1 could be published is Q4 2019, though a date in 2020 is much more likely. From the comments made, it doesn't seem that the current version (which will in all likelihood not be sent out for industry review) is largely identical to the one published for comment.
Siegfried Schmitt 13.05.2019

Many thanks for this valuable and highly topical information, Mr Schmitt!
Editorial Office Maas & Peither GMP Publishing 16.05.2019

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