EDQM: Automated CEP Submissions From 1 November 2025
The European Directorate for the Quality of Medicines and HealthCare (EDQM) is modernising its process for submitting Certificates of Suitability (CEP). As of 1 November 2025, the receipt of CEP applications will be automated.
In future, eCTD-based submissions must be validated in advance using
an appropriate eCTD validation tool and checked against the currently
applicable EU regional validation criteria. Any validation “fail errors”
must be corrected before submission.
The updated Common European Submission Portal (CESP) guide (PA/PH/CEP (13) 67 R3) reflects these changes to the CEP submission process.
Source:
EDQM: Newsroom
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