News on CEP 2.0: Specifications

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17/18 September 2024

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Once again, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has published further information on its website with regard to the "CEP 2.0". The presentation and content of section 3.2.S.4.1 Specification are now discussed and explained.

The EDQM points out that when applying for CEP 2.0, care must be taken to ensure that the information in the specification section corresponds to the information in the Ph. Eur. monographs and the country requirements (exclusively for European countries). Additional information and entries, for example to demonstrate compliance of the specifications with other pharmacopoeias (e.g. the USP), may lead to a delay in the granting or revision of the CEP 2.0.
However, if the applicant wishes to enter such information in this section, it is pointed out that this should be done in a separate table. This ensures that a clear distinction can be made between the obligatory European country requirements and non-European requirements that are not mandatory.

This and further information on the respective requirements can be found on the EDQM website and in the EDQM Guideline PA/PH/CEP (23) 21 on "New requirements for the content of the CEP dossier for chemical purity and for herbal drugs/herbal drug preparations according to the CEP 2.0".