EDQM: Policy for CEP Applications published for Comments

Recommendation

20/21 February 2024
Munich, Germany

GMP meets Regulatory Affairs
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

In June, the draft Certification Policy Document PA/PH/CEP(04) 1, 6R "Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use" was published on the EDQM (European Directorate for the Quality of Medicines & HealthCare) website for comments. Comments and remarks on this draft can be submitted until 15 September 2023. Following the consultation period, the final document will be published on the EDQM website.

This draft is intended to provide guidance for applicants for a CEP (Certificate of Suitability). It applies to all substances listed in the European Pharmacopoeia for which the certification procedure is relevant. These are mainly active substances, but excipients described in the monographs may also be included. However, the requirements for excipients may differ from the requirements for active substances.

The draft for comment explains that a new CEP application should contain three modules.
The facts to be included in modules 1-3 are listed and explained in detail in the policy document. In principle, the structure should be as follows:

• Module 1: Cover Letter and Complete Application 
• Module 2: Quality Overall Summary 
• Module 3: Structure according to the CTD, i.e. analogous to ICH M4.

The draft policy document can be found on the EDQM website.