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EMA: Revision of Annex 15 Delayed

  • News

In February 2026, the EMA published a concept paper on the revision of Annex 15 "Qualification and Validation" of the EU GMP Guide (we reported previously). The Agency has now released a corrected version containing a significantly revised timetable.

Originally, the first draft of the revised Annex was scheduled for public consultation in April 2026, with publication of the final guideline by the European Commission planned for December 2026. The revised timetable is now as follows:

  • First draft of the revised Annex: December 2026
  • Publication of the final guideline: April 2028

The concept paper itself remains unchanged. The main objectives of the revision are still to make Annex 15 mandatory for active substance manufacturers and to align it with the principles of ICH Q9(R1) Quality Risk Management.

Source:

EMA: Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and Validation

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