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New Requirements for the Content of the Chemical Purity | CEP 2.0


The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further clarification regarding the presentation and content of the “Specification” section (3.2.S.4.1) to all applicants preparing an application in CEP 2.0 format.

When completing section 3.2.S.4.1, applicants should focus on compliance with the European Pharmacopoeia (Ph. Eur.) monograph and with European regional requirements. Consequently, this section should not include parameters (analytical procedures and acceptance criteria) used by the manufacturer to demonstrate compliance with pharmacopoeias other than the Ph. Eur. (e.g. the United States Pharmacopeia).

Inclusion of such parameters may lead to delays in the CEP being granted or revisions being accepted and could also make it necessary to revise the CEP more frequently.

However, if a CEP holder nonetheless wishes to include these parameters in the specification section only to satisfy a regulatory requirement in another region (i.e. non-European regional requirement), they are strongly encouraged to provide the information in a separate table, clearly indicating that although the parameters are applied, they are not a European regional requirement. 

The suitability of the acceptance criteria or analytical procedures identified in this manner will not be evaluated by the EDQM, nor will the procedures be appended to the CEP, given that both the CEP holder and the EDQM recognise that they are not required in Europe.

More information on the new requirements can be found 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"

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