Concept Paper Annex 15 Revision published

In the working plans of the European Medicines Agency (EMA) a new revision of Annex 15 was proposed in 2024. Now the concept paper for this revision has been published on EMA´s website.

In the introduction it is described in detail that the N-nitrosamine impurities in sartan medicines triggered the revision of Annex 15. Why?

The reasons were mentioned in the "Lesson learnt" report about the sartan case management: the lack of a sufficient process and product knowledge during the development stage and GMP deficiencies by active substance manufacturers - including inadequate investigation of quality issues and insufficient contamination control measures, among other points. Therefore the report recommends to make Annex 15 mandatory for active substance manufacturers in order to address the shortcomings identified and to ensure quality and safety of medicines. So a drafting group has initiated the update process. Additionally it is planned to implement also parts of the updated ICH Q9 (R1) revision on quality risk management in the Annex 15 revision. The revised Annex 15 will be applicable to manufacturers of chemical and biological active substances. In the current version the use of Annex 15 is only optional for active substance manufacturers.

And the timelines?

There is a two month comment phase until April 2026 planned for the concept paper. At the end of 2026 a final draft version schould be available. 

You find the whole concept paper on EMA´s website.