On 1 November 2025, the EDQM introduced automation to improve its process for receiving CEP submissions. To fully benefit from this automation, applicants must submit the eCTD validation report as requested and in line with the requirements outlined below. While most submissions comply with this requirement, around 25% continue to be submitted without the requested eCTD validation report, leading to processing delays.
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 submission 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 (compressed folder) and in the top-level folder (outside the sequence folder). Example:
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Must include “validationreport”, “eVreport”, “validation report” or “eVR”
Not case sensitive |
PDF, RTF, HTML or MHTML |
In addition, all submissions should be done in line with the updated guide for using the CESP portal: Use of CESP to submit electronic documents to EDQM (PA/PH/CEP (13) 67 R3).
Failure to do so will lead to the application being rejected on receipt from the 1 April 2026.