CEPs: EDQM establishes New Procedure

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

By the end of 2022, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has adopted the document "Management of CEP guidelines and operational documents for the CEP procedure" and published it on its website. This document explains the new process for the development of supporting documentation related to CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia). It focuses on three types of documents, which are mentioned below:

• governance documents for the CEP procedure
• technical guidelines
• administrative or operational documents

It should be emphasised that a review procedure, which can be public or only for a specific target group, has now been introduced. This should help to increase the transparency of the processes, to communicate and announce updates and changes in a timely manner, and to provide the opportunity for comments.

Documents that are open for public comment will be available in a separate section on the EDQM website. In addition, there will be an announcement on the EDQM website. The consultation period will last between 3 weeks and 3 months, depending on the document.

Here, you will find the newly adopted document "Management of CEP guidelines and operational documents for the CEP procedure" and further information in the news section on the EDQM's website.