EDQM: CEP Report

Recommendation
19/20 March 2025
Barcelona, Spain
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective
In March 2023, the EDQM (European Directorate for the Quality of Medicines & HealthCare) once more prepared its "CERTIFICATION MONTHLY REPORT" on "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In addition to the number of new CEPs and CEP revisions, the report also includes information on withdrawn and expired CEPs. A comparison is always made with the data for the year 2023 and especially with the March data.
In addition, the number of inspections carried out by the EDQM is presented in an overview, with on-site inspections and remote inspections listed separately. This clearly shows that only on-site inspections were carried out in March. This leads to the fact that already now the number of on-site inspections significantly outweighs the number of remote inspections.
Here you can find the latest version of the "CERTIFICATION MONTHLY REPORT" and further information on the EDQM website.
Related GMP News
12.03.2025CMDh/HMA: Guidance Documents on Variation Notifications Updated
11.03.2025EMA: Renewal of Q&A Document for "Centralized Procedures"
11.03.2025Centralised Procedures: Q&A Documents also Updated for Biosimilars
29.01.2025CMDh/HMA: Updated Guidance Documents on Variation Notifications
29.01.2025EMA: Q&A Documents for "Centralized Procedures" revised
28.01.2025ANVISA recognises CEPs