EDQM: Revised Guidance on Sister File Applications
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised its Guidance on applications for “sister files” (PA/PH/CEP (09) 141). The revision is intended to support consistent application of the procedure and provide greater clarity on the classification and assessment of the corresponding CEP applications.
The guidance applies to CEP holders wishing to apply for another CEP for the same substance. This may be necessary where the conditions for revising the existing CEP are not met or where a separate CEP is sought for an alternative manufacturing process, manufacturing site or grade of the substance. The sister file procedure is intended to facilitate the submission and assessment of such applications.
In particular, the eligibility criteria for sister file applications have been clarified. Where a proposed manufacturing process involves different intermediates, starting materials or reagents, the application will generally be eligible only if the applicant can demonstrate that the underlying chemical principles and reaction mechanisms are the same as those described in the referenced CEP dossier.
The scope of the procedure has been extended to include CEP applications for sterile substances. TSE CEP applications remain excluded. The revised guidance also provides additional examples of acceptable situations and further clarifies the documentation to be submitted.
The revised guidance entered into force on 1 September 2026.
Source:
EDQM: Newsroom – Revised Guidance on applications for sister files
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