EDQM: Monthly CEP Overview

Drug Master File Procedures in the EU, the US and Japan - Live Online Training

Recommendation

17/18 September 2024

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

Again, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has prepared its "CERTIFICATION MONTHLY REPORT" on the subject of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) and has now published it in the newsroom of the EDQM website.

In addition to the number of new CEPs issued and revisions of CEPs, it also includes reports on withdrawn and obsolete CEPs. A comparison is always made between the data for the full year 2024 and the data for July 2024. The lists clearly show that most CEPs have been issued in July 2024 so far (compared to the previous months in 2024) and that the number of approved revisions is also comparatively high.
In addition, an overview shows the number of EDQM inspections carried out, with on-site inspections and remote inspections listed separately. This clearly shows that no remote inspections were carried out in 2024, yet.

Please find here the latest version of the "CERTIFICATION MONTHLY REPORT" and further information on the EDQM website.