The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published their draft revised version of the Guideline on requirements for revision/renewal of Certificate of Suitability (CEP) to the European Pharmacopoeia (Ph. Eur.) monographs (PA/PH/CEP (04) 02, 8R draft 1), aligning it with the latest EU regulatory changes.
What’s new (or clarified):
- The revised guideline reflects updates from the amended Commission Delegated Regulation (EU) 2024/1701 and related regulatory framework.
- It clarifies when a CEP revision or renewal is appropriate, and when a completely new CEP application is required (e.g. in case of substantial changes such as a new manufacturing site or a new synthesis route).
- It gives updated guidance related to implementation of “CEP 2.0”, including expectations around risk assessments.
What you should know:
- The draft guideline is now open for public consultation. Comments can be submitted until 16 January 2026.
- After the consultation period closes, a final version will be published, so now is the time to review and give feedback if your organisation is affected.
For those working in pharmaceutical development, regulatory compliance, or API supply, this update may impact your CEP lifecycle strategy, renewal plans, and documentation submission processes. Our team at Starodub specializes in guiding pharma companies through regulatory transitions like this one. Connect with us to explore how we can support you and help the approval process of your CEP dossiers.
Contact us directly by mailing your enquiry to [email protected] or visiting our website https://www.starodub.nl/
