EDQM: How should the Specification of a Substance be Presented in a CEP Application?

A new question has been added to the FAQs' section of the EDQM website under the subheading 'Application dossier'. You can find this in the section 'CERTIFICATION OF SUBSTANCES FOR PHARMACEUTICAL USE' under the main heading 'General information on the CEP procedure'. The new question reads: "How to present the specification for a substance in a CEP application?". The response provides clear guidance on the format in which the specification should be presented, the content it should include, and the possible approaches for presenting analytical methods and procedures. To illustrate this, the response includes an example of how a specification should be presented in the CEP dossier in section 3.2.S.4.1. It also demonstrates how additional specification parameters relevant to non-EU countries can be presented.

In addition to the question "How to present the specification for a substance in a CEP application?", an additional 11 questions are listed under the sub-section "Application dossier", which provide guidance on the application process. The answers to these questions are available in the "EDQM FAQs" section.