Supplement 11.7 of the European Pharmacopoeia (Ph. Eur.) available

Global Registration and Life Cycle Management for APIs

Recommendation

8-10 April 2025
Vienna, Austria

Global Registration and Life Cycle Management for APIs
Contents of the regulatory information in the ASMF and CEP

Supplement 11.7 of the European Pharmacopoeia (Ph. Eur.) is now available. All holders of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs) are advised to update their specifications and CEPs to comply with the new monograph by 01. April 2025.

A table shows all substances which are subject to the implementation of the changed or updated monographs. Beside the substance names, it also lists their classification (Case A or Case B). These are differentiated as follows:

Case A

The specifications of the substances belonging to this classification should be revised. If the relevant specification does not contain the addition "current version of the monograph", notification of the new specification is required with the next application for a CEP update. If this passage is included, the monograph can be implemented without submission with the next amendment of the CEP.

Case B

Monographs belonging to this category must always be submitted to the EDQM. The updated dossier, which shows that the new data of the revised monographs have been adopted, must be submitted within 3 months. CEP holders are required to update modules 1 and 3, and to provide appropriate explanatory information. After receiving the new data, the EDQM will review it and then inform the CEP holder of the results. A reissue of the CEP is not ruled out.

The list of categorized substances and further information on Supplement 11.7 to the European Pharmacopoeia (Ph.Eur.) is available on the EDQM website.