EU Opens Public Consultation on Revised GMP Guidelines
The European Commission’s Directorate-General for Health and Food Safety has launched a public consultation on the revision of several Good Manufacturing Practice (GMP) guidelines. The consultation is open from 7 July 2025 to 7 October 2025, 23:59 (CEST).
Who Should Participate
This consultation is aimed at public health stakeholders involved in GMP activities. Organisations representing such stakeholders are encouraged to collect input from their members and submit consolidated comments via the EU Survey tool.
Purpose of the Consultation
The update addresses the advancement of digital technologies and implementation of AI systems in pharmaceutical manufacturing. The objective is to ensure GMP guidelines continue to offer clear, practical, and relevant guidance for both manufacturers and national competent authorities.
The consultation includes:
Revision of Chapter 4 – Documentation
Revision of Annex 11 – Computerised Systems
Introduction of Annex 22 – Artificial Intelligence
These documents were drafted by the EMA GMDP-Inspectors Working Group in collaboration with PIC/S to support innovation and ensure harmonisation across regulatory systems.
Key Draft Revisions
Chapter 4 – Documentation
Updates emphasize the role of documentation in GMP compliance, integrating risk-management principles and supporting hybrid and digital formats. The draft highlights the management of electronic records, signatures, and data integrity.
Annex 11 – Computerised Systems
This revision mandates comprehensive application of Quality Risk Management (QRM) throughout the system lifecycle and includes stronger requirements for supplier oversight, audit trails, and system security.
Annex 22 – Artificial Intelligence
A new annex focused on AI and machine learning in pharmaceutical manufacturing. It includes requirements for model selection, validation, performance monitoring, training data, and human oversight.
Why This Matters:
These draft guidelines are designed to support innovation while ensuring harmonized and globally aligned GMP standards. If you’re part of the healthcare, biotechnology, or pharmaceutical ecosystem—especially if you deal with GMP compliance—this is a crucial opportunity to shape the future regulatory landscape.
How to Participate:
If you represent a stakeholder organisation: Coordinate internally and compile responses using the EU Survey Tool.
If you’re an individual contributor: You may submit your feedback directly via the EU Survey Tool, using the specific forms provided for each section.
Take part in the consultation before 7 October 2025 to help ensure that the future of pharmaceutical manufacturing remains both innovative and compliant.
Need help interpreting these updates or aligning your systems with the new standards? Contact Us to connect with expert regulatory consultants who specialize in GMP compliance and digital transformation in the healthcare sector.
