New EMA Guidelines and Revisions in GMP Area

Recommendation

2/3 September 2026
Copenhagen, Denmark

Root Cause Analysis
When “Human Error” isn’t enough: Successful Failure Investigation

The European Medicines Agency (EMA) has published a new version of the "3-year work plan for the Quality domain" for the period January 2021 - December 2023. The plan is being prepared by the GMP/GDP Inspectors Working Group (GMDP IWG) as part of the planned review after two years in March 2023. This also includes partly renewed timeframes for the revision of GMP specifications. Here is an overview:

Document

Planned modification

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.

Q1 2026

GMP Guide: Annex 11 (Computerised Systems)

To provide the European Commission with a final text for the amended chapter in order to assure data integrity in the context of GMP.

Q1 2026

Guidelines on GMP specific to ATMPS

Review the Guidelines in the light of new Annex 1 Manufacture of Sterile Medicinal Products and consider whether any updates are necessary.

Q4 2024

GMP Guide: Annex 15 Qualification and Validation

Review the annex in the light of new technology in facilities, products and processes and consider whether any updates are necessary. Following up on LLE recommendations, consider whether the scope can be extended to APIs.

Q2 2024

GMP Guide: Annex 16 Certification by a Qualified Person and Batch Release

Following up on LLE recommendations, consider revision of annex in order to provide additional guidance on batch traceability.

Q4 2024

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.

Q4 2024

GMP Guide: Annex 5 (Manufacture of Immunological Veterinary Medicinal Products)

To review comments received from concept paper stakeholder consultation and draft an updated text.

Q4 2024

GMP Guide: GMP for Novel Veterinary Medicinal Products

To provide the European Commission with a final text.

Q4 2023

GMP Guide: GMP for Autogenous Veterinary Vaccines

To provide the European Commission with a final text.

Q4 2023

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 2023

ICH Q13: Continuous Manufacturing

To support the EU members of the Expert Working Group (EWG) in developing the guideline.

Q4 2023

VICH: GMP for API’s for Veterinary Medicines

To support the EU members of the Expert Working Group (EWG) in developing the guideline.

Q4 2023

VICH: Other Q Guidelines for Veterinary Medicines

To support the EU members of the Expert Working Group (EWG) in any future adaptations of existing ICH Q Guidelines such as Q9/Q10 to veterinary medicines

Q4 2023

Implementing Act: GMP for Veterinary Medicinal Products

To provide the European Commission with scientific advice on GMP standards to be incorporated into an implementing act on GMP for veterinary medicinal products.

Q4 2023

Implementing Act: GMP for active substances for Veterinary Medicinal Products

To provide the European Commission with scientific advice on GMP standards to be incorporated into an implementing act on GMP for active substances for veterinary medicinal products.

Q4 2023