Corrigendum: Concept Paper on the Annex 15 Revision

In our news update from February 2026, we mentioned the publication of a concept paper on a further revision of Annex 15. This concept paper has now been reissued as a ‘corrigendum’. What are the changes?

We had outlined the reason for the planned changes in a news article providing a detailed analysis. The main aim of the revision is to make the inclusion of active substances in Annex 15 mandatory. Until now, this has been optional for active substance manufacturers. This affects both manufacturers of chemical active substances and those of biological active substances. The changes to quality risk management included in the revision of ICH Q9 (R1) are also to be incorporated.

The concept paper outlines the possibility that the 'Inspectors Working Group' and the 'PIC/S Subcommittee on GMDP Harmonisation', both of which are involved, may consider other relevant points or amendments that arise during the revision process. The ECA Validation Group took this passage as an opportunity to provide comprehensive comments on the concept paper.

A ‘corrigendum’ to the concept paper has now been published, dated 15 July 2026. The main changes relate solely to the timetable, which now reads as follows:

You can find the corrigendum on the EMA website:

• December 2026: Publication of the draft guideline
• March 2027: End of the consultation period
• November 2027: Approval by the EMA GMP/GDP Inspectors Working Group
• April 2028: Publication by the European Commission 
• April 2028: Adoption by the PIC/S GMP/GDP Harmonisation Sub-Committee

A transitional period of at least six months is expected to follow, after which the final document will come into full effect. Additionally, some minor editorial amendments have been made, and the document has been given a new reference number.

Conclusion: The corrigendum to the concept paper on revising Annex 15 mainly involves adjusting the timetable.

You can find the corrigendum on the EMA-Website