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Pharma IT Solutions
Quality & Compliance
Safety & Vigilance
23 may 2023
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is at the starting point of implementing various changes regarding the procedure and documentation for Certification of suitability to the monographs of the European Pharmacopoeia (CEP). This results in a “new-look” CEP called the “CEP 2.0” and impacts CEP applicants, CEP holders, and CEP users. Therefore, meetings were held on the 11th and 16th of May by the EDQM to address more information concerning these changes.
In the EU, the required information on chemistry, manufacturing and control of an active pharmaceutical substance can be submitted in three ways:
The latter only applies to existing active substances described in the European Pharmacopeia (Ph. Eur.). In general, a CEP has the advantage of avoiding subsequent reassessment.
After 30 years of service and in consultation with stakeholders, the EDQM has now redesigned the CEP to increase the user-friendliness and transparency of information. This resulted in a “new-look” CEP called “CEP 2.0”, formerly known as “the CEP of the future”. We want to draw your attention to the following main changes.,
The additional controls, such as impurities and solvents previously mentioned on the CEP, will be replaced by an Annex to the CEP showing the specification. The specification should be aligned with what has been assessed. It should therefore contain only information corresponding to the quality claimed. If no specific grade is requested, a corresponding test, such as microbiological controls, particle size, and polymorphism, should not be included.
The CEP dossier should be adapted similarly: it should only contain information corresponding to the quality claimed, and information not assessed and not approved should be deleted.
The analytical procedures described in the CEP dossier should be divided into two subsections:
Only the procedures in the second subsection will be enclosed as an Annex to the CEP.
The CEP dossier should be updated with the maximum daily dose, route of administration and treatment duration on which the control strategy and the specification are based.
The water quality during the last manufacturing steps will be mentioned on the CEP.
To raise awareness, the CEP holder should commit themselves via the updated application form to share pertinent information with their customers.
The company details (name and address) mentioned on the CEP should be complemented with the EMA SPOR/OMS Organisation (Org) and Location (Loc) ID. These are unique identifiers for organizations and their locations requested and registered via the EMA SPOR/OMS database. Therefore, the relevant CEP Modules should be adapted accordingly.
The declaration of access box mentioned on the CEP will be replaced by a separate letter of access.
A revised CEP will no longer be issued for approved changes that do not impact the CEP content, even if it concerns major changes.
Accordingly, a renewed CEP will no longer be issued at the end of the renewal procedure, and the part of the numbering system related to the renewal (i.e. R0 or R1) will be deleted. If changes are introduced at renewal that impact the CEP content, a revised CEP will be issued.
Implementing CEP 2.0 impacts CEP applicants, CEP holders, and CEP users. All changes should be fully implemented for new CEPs and during upcoming renewal procedures. Initially, the changes should be implemented only partly for revisions and notifications. However, at a later stage, all existing CEPs are expected to switch to CEP 2.0.
Implementations start from June 1st, whether the first CEPs 2.0 are expected to be issued in Q3.
Keen to know how this implementation impacts your CEP or MA? Want to know about additional changes and details? We can support you!
Building on decades of experience in the EU regulatory requirements, Zwiers Regulatory Consultancy, a ProductLifeGroup Company, provides up-to-date support for expert advice and effective CMC writing.
Contact us to find out more here.
 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-summary-requirements-active-substances-quality-part-dossier-revision-1_en.pdf, (assessed May 2023).
 https://www.edqm.eu/en/what-is-the-cep-2.0, (assessed May 2023).
 https://www.edqm.eu/en/-/093-news-requirements-for-the-content-of-the-cep-dossier-according-to-the-cep-2.0-and-updated-application-forms, (assessed May 2023).
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