EDQM issues draft revised guideline on revision/renewal of CEPs for public consultation

2nd December 2025

EDQM issues draft revised guideline on revision/renewal of CEPs for public consultation

Summary: The draft revision of the CEP-revision/renewal guideline clarifies how CEP holders should inform EDQM about changes — from administrative updates to quality-relevant modifications — and when a full new CEP application is required. It streamlines submission processes (including e-submission requirements), refines classification of changes (minor, major, notifications), and emphasises that certain modifications (e.g. a substantially different synthesis route or a new manufacturing site outside the same group) will not be accepted as a simple revision or renewal. The update aims to improve transparency, maintain consistency of API standards under Ph. Eur., and ensure robust lifecycle management of CEP-guarded substances. 

Link: EDQM draft revised guideline on revision/renewal of Certificates of Suitability to European Pharmacopoeia monographs – for public consultation

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