EC - Stakeholders’ Consultation on EudraLex Volume 4

8th July 2025

EC - Stakeholders’ Consultation on EudraLex Volume 4 Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22

In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of Good Manufacturing Practice (GMP) guidelines is essential to ensure that they continue to provide clear, practical and relevant guidance for manufacturers and national competent authorities. 

Deadline 7th October 2025

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