As an applicant using the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure, you play a central role in ensuring the smooth processing of your request. One of the best ways to accelerate the process is by improving the quality of your submission. Incomplete or inconsistent dossiers often lead to blocking issues or requests for additional information, which can significantly delay the outcome.

To help facilitate your CEP application and assist you in preparing a high-quality dossier, the European Directorate for the Quality of Medicines & HealthCare (EDQM) provides a range of guidance documents and tools:

 Content of the dossier for chemical purity and microbiological quality (PA/PH/CEP (04) 1, 7R);

Top ten deficiencies in new applications (PA/PH/CEP (24) 10);

Template for the Quality Overall Summary (PA/PH/CEP (15) 26 1R, January 2024).

You are also requested to bear in mind the principles and requirements outlined in ICH Quality Guidelines and related guidance from the European Medicines Agency (EMA). For example:

 risk assessment for nitrosamines and compliance with EMA Q&A are core requirements;

starting materials should be defined in line with ICH Q11 , along with its decision tree and Q&A document;

mutagenic impurities must be addressed according to ICH M7.

The ICH and EMA guidelines are referenced in the EDQM document “Content of the dossier for chemical purity and microbiological quality” (listed above) and are essential for a compliant submission.

Valuable training resources are available in the EDQM e-learning catalogue, including training modules 5 to 9, which provide practical insights into dossier preparation.

By leveraging these tools and aligning your submission with current expectations, you can significantly improve your chances of a smooth and rapid CEP evaluation.

See also:

“Certified for success” – Register now for the CEP conference

“How to read a CEP” – Revised guideline now available!

Reminder: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications