ECA Validation Group comments on Concept Paper regarding the Revision of Annex 15
Recommendation
19/20 May 2026
Hamburg, Germany
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In February 2026, the EMA published a concept paper announcing a further revision of Annex 15 to the EU GMP Guidelines. The last revision of Annex 15 was in 2015 and introduced significant changes compared to the original document from 2001. This concept paper was open for comments until 9 April 2026. The ECA Validation Group took advantage of this opportunity. What comments were made?
The main changes mentioned in the concept paper relate to the full integration of active substances into Annex 15. However, it was also noted that further changes to the current Annex 15 might arise in the course of the revision. The ECA Academy's Validation Group took advantage of the opportunity to comment and submitted its comments to the European Medicines Agency (EMA) in good time. The group used the opportunity not only to comment on the inclusion of active substances, but also on the document as a whole.
For example, it was suggested that inconsistencies in the glossary of the current version of Annex 15 be resolved. Furthermore, clarification was requested, amongst other things, regarding the new term "Validation Master File" in the concept paper, as this term does not appear either in the GMP guidelines themselves or in the annexes.
The detailed list of all comments can be found on the ECA Foundation website.
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