The European Directorate for the Quality of Medicines & HealthCare (EDQM) has announced a major update to the submission process for Certificates of Suitability (CEP) applications, introducing automation measures to enhance the quality, efficiency, and traceability of dossiers.
Starting November 1, 2025, all applicants will need to follow the new electronic submission requirements to ensure compliance and avoid delays during the validation phase.
eCTD Submissions
For any submission containing eCTD sections, applicants must now include a validation report that complies with the current EU regional validation criteria.
Key points to remember:
- The validation report must be provided as part of the submission package (zipped folder) and placed in the top-level directory (outside the sequence folder).
- The file should be clearly named, using recognizable terms such as “validationreport”, “eVreport”, or “validation report”.
- Accepted formats: PDF, RTF, HTML, or MHTML.
This ensures transparency and consistency in the review process, allowing the EDQM to verify eCTD structure and content more efficiently.
CESP Portal Usage
When using the Common European Submission Portal (CESP), applicants must:
- Select the correct “Regulatory Activity” to ensure proper routing of submissions.
- Make sure the “Substance Name” matches exactly the one used in the current CEP or the corresponding Ph. Eur. monograph.
- In cases of grouped revisions, include the word “Grouped” in the CESP comment box to clearly indicate that multiple dossiers are impacted by the same modification.
These improvements are designed to streamline submission management and facilitate the identification of linked or related applications.
Updated Guidance
The official guideline PA/PH/CEP (13) 67 R3 has been revised to incorporate these new digital requirements.
All applicants are encouraged to familiarize themselves with the update and ensure their submission workflows are aligned before November 2025 to prevent validation failures or submission rejections.
You can read the full EDQM communication here:
EDQM – Changes to e-Submission Requirements for CEP Applications
Need Support? Our Regulatory Operations team can help you adapt your processes, validate eCTD structures, and optimize submission quality in line with the new EDQM standards.
Contact us: [email protected]
