The EDQM will soon be introducing automation to improve its process for receiving CEP submissions. As of 1 November 2025, applicants will have to comply with the following requirements:
- The eCTD validation report must be provided as part of eCTD submissions: Submissions with eCTD sections must be validated against the currently applicable EU region validation criteria using an appropriate eCTD validation tool. Any eCTD validation fail errors must be corrected before submitting to the EDQM. The eCTD validation report location, naming and file format requirements are described below.
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eCTD Validation report |
eCTD Validation report location |
eCTD Validation report name |
eCTD Validation report format |
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Required for eCTD submissions. |
Must be included as part of the submission (zipped folder) and in the top-level folder (outside the sequence folder). Example:
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Must include ‘validationreport’, ‘eVreport’ or ‘validation report’
Not case sensitive |
PDF, RTF, HTML or MHTML |
- Use of the CESP:
- The relevant “Regulatory Activity” must be selected when preparing the delivery file on the CESP portal to ensure the submission is correctly distributed.
- The name provided in the “Substance Name” field must be identical to the name on the current CEP or its corresponding monograph and must not include any additional text (subtitle, “EP”, “Ph.Eur.”, etc.).
- If the submission is for a grouped revision (several dossiers affected by the same change(s)), the word “Grouped” must be included in the comment box when preparing the CESP delivery file.
The guide for using the CESP to submit electronic documents to the EDQM has been updated to reflect these changes (PA/PH/CEP (13) 67 R3).
It is important that these updated requirements are taken into account when preparing and submitting applications. Failure to do so will delay validation or may lead to the application being blocked on receipt.