Discover the latest updates on human variation classification in eAF. The updated Variation Regulation Classification Guideline is now available in the interactive PDF eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version. To sustain this change a Q&A session was held on 8 January.
date: 19/01/2026
The updated human Variation Regulation Classification Guideline is now available in the interactive PDF eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.
Submissions using these new versions should be made going forward. For details on exceptions and scope applicability, consult the EMA's dedicated page: Guidance on the application of the revised variations framework | European Medicines Agency (EMA).
To support this transition, the EMA eAF team hosted a Q&A Clinic on 8 January 2026 (10:00-11:00 CET). The session focused on addressing questions about the new variation classification in eAF. The event's recording is available and accessible at the following link: https://www.ema.europa.eu/en/events/qa-clinic-new-variation-classification-eaf
Stay informed and ensure compliance by reviewing the updated guidelines and leveraging EMA resources for smooth application processes.