Starting 01 October 2025, the optional use of the new EU eCTD Module 1 Specification v3.1.1 and Validation Criteria v8.2 will come into effect, with mandatory implementation required from 01 December 2025. The updated specifications introduce several changes that require preparation from industry stakeholders.
This blog post provides a clear overview of the key updates to help you understand what will be changing and how to stay compliant.
The EU eCTD M1 Specification v3.1.1 introduces several updates, including changes to the tracking table for EDQM. Additionally, new examples have been added for product numbers and procedure numbers related to work-sharing and super-grouping. A detailed overview of these changes can be found in the tables below.
EMA EU eCTD M1 Specification v3.1.1 – Changes in Detail
| Section of the document |
Change |
| General architecture of Module 1 |
Mention related to “super-grouping” (page 10) |
| General architecture of Module 1 |
New examples provided for the pre-submission phase product number |
|
Appendix 1: The EU Module 1 XML Submission
|
Element “number”: examples updated for worksharing and super-grouping (based on the new EMA case management system (IRIS))
|
| Appendix 2: Directory/File Structure for Module 1, Element 6 |
Exception added to tracking table for EDQM submissions |
EMA Validation Criteria v8.2 – Changes in Detail
| Criterion number in 8.1 |
Criterion number in 8.2 |
Change |
| 14.BP5, 14.BP7 |
14.BP5, 14.BP7 |
Clarifications added for Super-grouping |
| 15.11, 15.12 |
15.11, 15.12 |
Added clarification that the tracking table is not needed for EDQM Submissions |
| 16.6 |
16.6 |
Added more details on how to identify electronic application forms created with the PLM Portal and the ones created with the interactive PDF
Comment: "For easier identification of the PLM Portal web-based eAFs vs the interactive pdf eAF, the following details may help; For the eAFs generated from the PLM Portal that have not been altered further by any other tool, in the document properties the name of the application is: PDF generator and the author is 'European Medicines Agency'.
For the interactive PDF eAF the name is 'Designer 6.5'.
The PLM Portal eAF version number starts with 2.x, and for the interactive PDF, the version number starts with 1.x.
The check on FHIR XML attachment is not applicable for the interactive PDF eAFs. The interactive PDF eAF must not contain any additional attachments." |
| - |
16.7 |
New rule to check there are no attachments in the interactive PDF eAF
Validation Criterion: "The interactive PDF eAFs (from eSubmissions website) must not contain any attachments." |
When to use EMA’s new version of the validation criteria v8.2?
The new version of EMA’s validation criteria v8.2 has been published on the eSubmission website. It is related to the EU Module 1 Specification version 3.1.1 and should be used in case of submitting a new sequence according to EU M1 specification v3.1.1.
The new validation criteria will be used for the technical validation for all v3.1.1 electronic submissions received as of 01 December 2025 to the National Competent Authorities and EMA. The Util files remain the same as for version 3.1.
|
Timeline of respective updates in EXTEDO’s products
Our customers can rely on a reliable implementation of the new requirements in our solutions before they become mandatory:
EURSvalidator: Updates included in EURSvalidator 25.07, available from 31 July onwards
EURSnext: No Update required
eCTDmanager and eSUBmanager: No update is required for eCTDmanager and eSUBmanager, as the DTD remains unchanged. EU M1 DTD Version 3.1 is already integrated into the solution and is fully compatible with the new validation rules introduced in version 8.2.
|
.png)
%20(2).png)
