EMA Updates Stability Testing Guidance for Marketing Authorisation Variations

In December 2025, the European Medicines Agency (EMA) published Revision 3 of the Guideline on stability testing for applications for variations to a marketing authorisation. The revised guideline entered into force on 15 January 2026 and reflects the requirements introduced by the updated Variations Regulation, Commission Delegated Regulation (EU) 2024/1701, which amends Regulation (EC) No 1234/2008.

Revision 3 clarifies and aligns the stability data expectations for variation submissions with the current regulatory framework. The guideline covers general requirements as well as specific data requirements for Type I and Type II variations, including detailed subcategories for Type II changes. While the overall structure remains familiar, most updates are concentrated in Chapters 4, 5, and 6. Notably, the number of listed sub-items for Type II variations has been reduced from 19 to 17.

Annex I and Annex II remain largely unchanged, continuing to support applicants with practical guidance on stability studies and commitment batches.

25-01-2026