EMA: GMDP IWG 3-Year Work Plan (2025–2027)
The 3-year work plan for the EU GMDP Inspectors Working Group (IWG) aligns with Network Strategy goals, emphasising supply chain integrity, product quality, enhancing inspector capacities, and the impact of new manufacturing technologies. 10 documents of the GMP Guide will be revised or newly launched.
Strategic Goals
The work plan is designed around five key strategic objectives aligned with the Network Strategy and Regulatory Science Strategy:
- Enhance traceability and security in medicine supply chains
- Build inspector capacity at EU and international levels
- Reinforce product quality through harmonized guidance
- Encourage supply chain resilience
- Analyze implications of new manufacturing technologies
The plan is flexible, acknowledging potential updates with the upcoming EMA network strategy 2028 review.
Tactical Goals and Activities
Key Focus Areas
- Improve information sharing through EudraGMDP database
- Implement new Veterinary Regulation
- Develop GDP inspector training curriculum
- Support international API and finished product inspection programs
- Enhance data integrity guidance
- Analyze new manufacturing technologies
- Support supply chain resilience
Guideline Activities
Planned updates to the EU GMP Guide include aspects of data integrity, novel veterinary medicines, nitrosamines and the extension of the scope of Annex 15 to APIs.
What is striking in comparison to last year's plan is that the deadline for Appendix 15 has been postponed by one year.
Actually, the publication of drafts of Appendix 15, Chapters 1 and 4, is expected in the near future. We will report further.
| EU GMP Guide | Comment | Target Date |
| Chapter 1 Pharmaceutical Quality System | Amendment to incorporate elements of ICH Q9(R1) | Q1 2026 |
| Chapter 4 Documentation | Amendment to assure data integrity (parallel to Annex 11) | Q1 2026 |
| Annex 3 Radiopharmaceuticals | Review and update | Q4 2026 |
| Annex 4 Veterinary Medicinal Products | Review of comments recieved from concept paper consultation, draft an updated text | Q1 2026 |
| Annex 5 Immunological Veterinary Medicinal Products | Review of comments recieved from concept paper consultation, draft an updated text | Q1 2026 |
| Annex 6 Medicinal Gases | Review and update | Q4 2026 |
| Annex 11 Computerised Systems | Amendment to assure data integrity (parallel to Chapter 4) | Q1 2026 |
| Annex 14 Medicinal Products Derived from Human Blood or Plasma | Review and update, taking into account Regulation (EU) 2024/1938 | Q4 2027 |
| 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 |
| 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 |
| 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 |
International Collaboration
- Continued work with Mutual Recognition Agreements (MRAs)
- Collaboration with ICMRA, EDQM, and regulators from India, China, and Africa
- Support for international inspection initiatives
- Workshops and training programs
Stakeholder Engagement
- Annual meetings with industry associations
- Workshops on quality risk management
- Cross-domain activities with various working parties
- Collaboration with European Commission on legislative developments
Operational Goals
Pre-Authorization Activities
- Support Innovation Task Force
- Contribute to scientific advice
- Provide GMP expertise for marketing authorizations
Evaluation and Supervision
• Develop re-inspection programs
• Review GMP provisions for innovative technologies
• Leverage international regulatory information
• Contribute to managing medicine shortages
Source:
EMA: The 3-year work plan for the Inspectors Working Group
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