EMA's Plans for the next three Years
Recommendation
27/28 May 2025
Supervision of the Pharmaceutical Quality System: Challenges and Opportunities
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The European Medicines Agency EMA has published a new version of the '3-year work plan for the Inspectors Working Group' for the period January 2025 to December 2027. The plan is prepared by the GMDP Inspectors Working Group (GMDP IWG). It also includes some updated timeframes for the revision of GMP requirements. Here is an overview:
| Document | Planned Changes | Time Frame |
| GMP Guide: Chapter 1 (Pharmaceutical Quality System) | To provide the European Commission with a final text for the amended chapter in order to incorporate elements of ICHQ9 R1. | Q1 2026 |
| GMP Guide: Chapter 4 (Documentation) | To provide the European Commission with a final text for the amended chapter in order to assure data integrity in the context of GMP. This would be in parallel with similar consideration of Annex 11 (Computerised Systems). | Q1 2026 |
| GMP Guide: Annex 3 Manufacture of Radiopharmaceuticals | To provide the European Commission with a final text for an amended Annex 3 following a review and update of the Annex to reflect current state of the art. | Q4 2026 |
| GMP Guide: Annex 4 (Manufacture Of Veterinary Medicinal Products Other Than Immunological Veterinary Medicinal Products) | To review comments received from concept paper stakeholder consultation and draft an updated text and to provide the European Commission with a final text. | Q1 2026 |
| GMP Guide: Annex 5 (Manufacture Of Immunological Veterinary Medicinal Products) | To review comments received from concept paper stakeholder consultation and draft an updated text and to provide the European Commission with a final text. | Q1 2026 |
| GMP Guide: Annex 6 Manufacture of Medicinal Gases | To provide the European Commission with a final text for an amended Annex 6 following a review and update of the Annex to reflect current state of the art. | Q4 2026 |
| GMP Guide: Annex 11 (Computerised Systems) | To provide the European Commission with a final text for the amended annex in order to assure data integrity in the context of GMP. This would be in parallel with similar consideration of Chapter 4 (Documentation). | Q1 2026 |
| GMP Guide: Annex 14 Manufacture of Medicinal Products Derived from Human Blood or Plasma | To provide the European Commission with a final text for an amended Annex 14 following a review and update to take into account Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application. | Q4 2027 |
| GMP Guide: Annex 15 Qualification and Validation | To provide the European Commission with a final text for an amended Annex 15 in the context of new technology in facilities, products and processes and following up on LLE recommendations, and extend the scope to APIs as well as to reflect changes from the revised ICH Q9 R1 on Quality Risk Management. | Q4 2026 |
| GMP Guide: Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products | Review the Guidelines in collaboration with CAT and the European Commission following the publication of a new regulation on standards of quality and safety for substances of human origin intended for human application and need to update legal references and definitions. Review the Guidelines in the light of new Annex 1 Manufacture of Sterile Medicinal Products and consider whether any updates are necessary. | Q4 2026 |
| GDP Guide | Develop a Q&A to provide guidance to WDA Holders on performing risk assessments on the verification of authenticity of medicinal products at risk of falsifications. | Q4 2026 |
| ICH Q12: Lifecycle management | To agree an EU approach to documenting and communicating the effectiveness of a manufacturing site’s Pharmaceutical Quality System. | Q4 2025 |
The plans for this are not included in the work plan, but can be found in the 'Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2024'. Work on the following supplementary guidelines is continuing:
- Q&A on the QP Declaration - Targeted stakeholder consultation
- Q&A on Decentralised Manufacturing - Drafting ongoing
It is not stated whether new ones will be added.
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