EMA Publishes Concept Paper for Revision of Annex 15 Following Nitrosamine Findings

The European Medicines Agency (EMA) has released a concept paper outlining plans to revise Annex 15 as part of its 2024 work program. The update was prompted by lessons learned from the discovery of N-nitrosamine impurities in sartan medicines.

According to the “lessons learned” report on the sartan case, root causes included insufficient process and product knowledge during development and GMP shortcomings among active substance manufacturers. These deficiencies involved inadequate investigations of quality defects and weak contamination control strategies. To address these gaps, the report recommends making Annex 15 mandatory for active substance manufacturers, rather than optional as it is under the current framework.

A drafting group has begun work on the revision, which will also incorporate elements of the updated ICH Q9 (R1) guideline on quality risk management. The revised Annex 15 is expected to apply to both chemical and biological active substance manufacturers.

A two-month public consultation runs until April 2026, with a final draft anticipated by the end of 2026.

16-02-2026