EMA Unveils 2026–2028 Work Plan for GMP Updates

The European Medicines Agency has released a new three-year work plan (2026–2028) for the Inspectors Working Group, developed by the GMDP Inspectors Working Group. The plan outlines key updates to Good Manufacturing Practice (GMP) guidelines, including revised timelines for several chapters and annexes.

By the end of 2026, final texts are expected for major areas such as Pharmaceutical Quality Systems (Chapter 1), Documentation (Chapter 4), Annex 15 (Qualification and Validation), and Annex 22 focusing on Artificial Intelligence. Additionally, a review of GMP guidelines for advanced therapy medicinal products is planned, along with clarification on implementing the ICH Q12.

Looking ahead to 2028, revisions are scheduled for critical GMP sections including Premises and Equipment, Production, Outsourced Activities, and Self-Inspection, along with annexes covering radiopharmaceuticals, medicinal gases, and plasma-derived products.

The roadmap reflects a comprehensive effort to modernize GMP standards in line with evolving technologies and regulatory needs.

01-04-2026