Commission launches consultation on revised GMP quality system guidelines
The European Commission's Directorate-General for Health and Food Safety has opened a consultation on proposed updates to Chapter 1 of the Good Manufacturing Practice (GMP) guidelines. The revision aligns with the International Council for Harmonisation (ICH) Q9(R1) guideline on Quality Risk Management, introducing strengthened requirements for knowledge management and risk assessment across product lifecycles. Key changes include new provisions for shortage prevention, clarified product quality review requirements, and guidance on product grouping strategies. The amendments aim to modernise regulatory frameworks while ensuring consistent product quality and availability. Public health stakeholders involved in GMP activities can submit responses via EU Survey tool. Consultation closes 3 December 2025.