EMA Plans for the next three Years
Recommendation
11/12 February 2025
Heidelberg, Germany
Medicinal Products/Drugs meet Medical Devices
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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 2024 to December 2026. The plan is prepared by the GMDP Inspectors Working Group (GMDP IWG). It also includes some updated timeframes for the revision of GMP requirements.
Chapter 4 on documentation and Annex 11 (Computerised Systems) to the EU GMP guidelines, which are also related, are due to be submitted to the EU Commission as a final text in the first quarter of 2026. At least that's what is planned. In the same year, but in the fourth quarter, the specific GMP guidelines for ATMPs will then be reviewed to determine whether changes are necessary. There are also supposed to be changes to other annexes (Annex 3, Annex 4, Annex 5, Annex 6, Annex 15, Annex 16). However, no further changes to guidelines are planned for this year (2024).
EMA plans at a glance
Following you can find an overview of the EMA plans:
| Document | Planned Change | Timeframe |
| 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). To work with GCP IWG, GLP IWG and PhV IWG on this topic. | Q1 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). To work with GCP IWG, GLP IWG and PhV IWG on this topic | Q1 2026 |
| Guidelines on GMP specific to ATMPS | 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 |
| 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. 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. 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 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. | Q4 2025 |
| GMP Guide: Annex 16 Certification by a Qualified Person and Batch Release | To provide the European Commission with a final text for an amended Annex 16 following up on LLE recommendations. | Q4 2025 |
| GMP Guide: GMP for Novel Veterinary Medicinal Products | To provide the European Commission with a final text. | Q4 2025 |
| GMP Guide: GMP for Autogenous Veterinary Vaccines | To provide the European Commission with a final text | Q4 2025 |
| GMP and Marketing Authorisation Holders | To revise the paper in line with recommendations from the Nitrosamines LLE, to strengthen guidance for MAHs in terms of having adequate quality agreement with manufactures. | Q4 2025 |
| ICH Q12: Lifecycle Management | To support the EU members of the Expert Working Group (EWG) in developing the training materials on the guideline with particular emphasis on GMP inspection and Pharmaceutical Quality System aspects, in liaison with PIC/S initiative. | Q4 2025 |
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