Changes to e-Submission Requirements for CEP Applications
As part of continuous digital transformation in regulatory processes, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has introduced automation to enhance the management and review of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) submissions. These updates, effective 1 November 2025, aim to streamline validation procedures and ensure the accuracy of electronic submissions.
Key Updates Introduced by the EDQM- Mandatory eCTD Validation Report Applicants submitting in eCTD format must now include a validation report as part of the submission package. The eCTD must be validated against the current EU regional validation criteria using an appropriate validation tool, and any errors must be corrected before submission. The validation report should:
- Be included within the submission (compressed folder) and placed in the top-level directory (outside the sequence folder).
- Contain one of the following keywords in the filename: “validationreport”, “eVreport”, or “validation report” (case-insensitive).
- Be provided in PDF, RTF, HTML, or MHTML format.
- Updated Use of the CESP Portal When submitting via the Common European Submission Portal (CESP):
- Select the correct Regulatory Activity to ensure proper routing.
- The Substance Name must match exactly with the current CEP or its related monograph — avoid any additional text such as “EP” or “Ph. Eur.”
- For grouped revisions (multiple dossiers with the same change), include the term “Grouped” in the CESP comment box.
The Guide for CESP submissions (PA/PH/CEP (13) 67 R3) has been updated accordingly.
At Masuu Global, we continuously monitor such regulatory changes to keep our clients informed and compliant. For assistance in preparing or validating CEP submissions, our regulatory experts are here to help ensure smooth submissions and minimize approval delays.
The EDQM’s updated e-submission requirements for CEP applications represent a critical evolution in the regulatory lifecycle for pharmaceutical substances. For API manufacturers and regulatory affairs teams servicing EU market access, preparation is non-negotiable.
With its proven expertise in regulatory affairs, eCTD submissions and CEP dossier management, Masuu Global is well positioned to guide and support organization’s through this regulatory transition—ensuring compliance, accuracy, and on-time submissions.
