The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised the “Guideline on requirements for revision and renewal of certificates of suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 02) to introduced new e-submission requirements for CEP applications, marking a step toward more automated, accurate and efficient processes.
The draft revised guideline is now available for public consultation until January 16, 2026. After the consultation phase, the final guideline will be posted on the EDQM website.
As of 1 November 2025, the EDQM will implement automation to streamline CEP submission processes. As part of this change, the EDQM will require that applications submitted with electronic common technical document (eCTD) be validated according to the latest EU regional criteria. Applicants must now perform the task using an appropriate eCTD validation tool.
The Directorate has provided some rules for file naming and placemement for the submission of the validation report and instructions on file format requirements.
To ensure smooth submission of applications, the EDQM has also updated the guidelines (PA/PH/CEP (13) 67 R3) on the use of the Common European Submission Portal (CESP) to reflect all the changes made.
SOURCES:
https://www.edqm.eu/en/-/changes-to-e-submission-requirements-for-cep-applications