On 7 July 2025, the European Commission released draft revisions to EU GMP Chapter 4 (Documentation), Annex 11 (Computerised Systems), and the new Annex 22 (Artificial Intelligence) for public consultation. These updates aim to align GMP standards with advances in digital systems, AI, and documentation practices.
🔍 Who Should Participate
Public health stakeholders, including GMP manufacturers, importers, and quality professionals, should review and contribute feedback.
📢 How to Submit Feedback
Stakeholder organizations should gather comments from members, compile them, and submit through the EU Survey tool.
🗓 Consultation Period
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Start: 7 July 2025
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Deadline: 7 October 2025, 23:59 (CEST)
🔗 Link: Click Here