EMA: New Plans for the EU GMP Guide
EMA published the GMDP Inspectors Working Group’s new 2026-2028 work plan and its 2025 annual report.
The work plan points to upcoming activity on Chapter 1, Annex 11, Annex 22, veterinary GMP implementation, inspector training, EudraGMDP modernisation and publication of new Q&As such as 3D printing. The annual report confirms the group’s continuing role in harmonising GMP and GDP activities across the network.
During the coming years, a comprehensive revision of the EU GMP Guide is anticipated. Most deadlines have been set for Q4 2028.
Detailed guideline activities:
|
EU GMP Guide |
Comment |
Target date |
|
Chapter 1 Pharmaceutical Quality System |
Amendment to incorpoarate elements of ICH Q9(R1) |
Q4 2026 |
|
Chapter 3 Premises and Equipment |
· Review against current state of the art · Future update of the Veterinary GMP Implementing Acts? · Parallel with the update of Chapter 5 |
Q4 2028 |
|
Chapter 4 Documentation |
Amendment to assure data integrity (parallel to Annex 11) |
Q4 2026 |
|
Chapter 5 Production |
· Review against current state of the art · Future update of the Veterinary GMP Implementing Acts? · Parallel with the update of Chapter 3 |
Q4 2028 |
|
Chapter 7 Outsourced Activities |
· Review against current state of the art · Future update of the Veterinary GMP Implementing Acts? · Parallel with the update of Chapter 9 |
Q4 2028 |
|
Chapter 9 Self-Inspection |
· Review against current state of the art · Future update of the Veterinary GMP Implementing Acts? · Parallel with the update of Chapter 7 |
Q4 2028 |
|
Annex 3 Radiophamaceuticals |
Review and update |
Q4 2028 |
|
Annex 6 Medicinal Gases |
Review and update |
Q4 2028 |
|
Annex 11 Computerised Systems |
Amendment to assure data integrity (parallel to Chapter 4 and Annex 22) |
Q4 2026 |
|
Annex 14 Medicinal Products Derived from Human Blood or Plasma |
Review and update, taking into account Regulation (EU) 2024/1938 |
Q4 2028 |
|
Annex 15 Qualification and Validation |
Update in the context of new technology in facilities, products and processes and following up on Heads of Medagencies‘ (HMA) nitrosamine recommendations, extend the scope to APIs and reflect changes from ICH Q9(R1) |
Q4 2026 |
|
Annex 22 Artificial Intelligence |
New Annex to
assure use of AI in the context of GMP |
Q4 2026 |
|
ATMP GMP Guidelines |
Review and update together with the Committee for Advanced Therapies (CAT) and the EC (new regulation on standards of quality and safety for substances of human origin, new GMP Annex 1) |
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 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 |
Source:
EMA: Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group
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