The European Medicines Agency (EMA) has announced the release of the latest version of the EU eCTD M1 Specification, version 3.1, alongside the updated Validation Criteria version 8.0. These updates are essential for ensuring that electronic Common Technical Documents (eCTDs) meet the latest regulatory standards within the European Union.
Starting from December 1, 2024, eCTDs that comply with either EU M1 v3.0.4 or v3.1 and validation criteria v7.1 or v8.0 will be accepted. However, from March 1, 2025, only eCTDs conforming to EU M1 v3.1 and validation criteria v8.0 will be accepted.
Additionally, the EMA has specified the accepted file formats for eCTD submissions in the EU Accepted File Formats for eCTD Version 1.0. While the generally accepted file format is PDF, there are specific cases where other formats will be exceptionally accepted within the eCTD modules. For detailed guidance on these exceptions, please refer to the list of accepted file fomats permissible uses.
We have compiled a detailed overview of these updates in this blog post. Have a look at the changes in the implementation guide and the Util files and find out what is new in the upcoming Validation Criteria version 8.0.
1.eCTD M1 Specification Version 3.1: Changes in the Implementation Guide
| Section of the Document |
Change |
| File formats |
Explanations added about the generally accepted file format (i.e. PDF) and the reference to the newly introduced Annex “EU Accepted file formats for eCTD”. |
| Use of electronic signatures |
Name of the chapter updated from “Use of authentication measures” to “Use of electronic signatures” and clarifications added for the topic. |
| Handling of Empty or Missing eCTD Sections |
Paragraph added related to information about missing eCTD sections |
| General architecture of Module 1 |
Paragraph added related to the recommendation on not resending existing documents |
| Envelope |
Clarification added
|
|
Appendix 1
|
Typo corrected for the sample UUID
New submission type added (Article-18)
New submission unit added (Re-examination)
Clarification added for submission units “closing” and “consolidating”
|
Appendix 1 - Example of the use of the Related Sequence and the Submission Unit type elements
|
Clarification added
Introduced paragraph with explanation for the sequence number
Element 0010 – rewording
|
| Appendix 1 - Example of how to use the submission type ‘withdrawal’ and how to indicate the withdrawal of a single regulatory activity or a strength or pharmaceutical form |
Rewording and paragraph with reference to Q&A document added
|
| Appendix 2 |
Element 6 (tracking table) – rewording
Element 9 – clarifications added
Element 24 – rewording
Element 52 – Clarification added
Element 70 – Clarification added
|
| Appendix 2.1 (Country codes) |
New code “xi” (UK(NI)) added
Explanation for “uk" added
|
| Appendix 2.2 (Language codes) |
Appendix 2.2 (Language codes) New code “ga” (Irish)
|
| Appendix 2.3 |
Explanation added for Interpack package label
|
| Appendix 2.4 (Agency codes and names) |
Multiple names updated
|
| Appendix 3 |
Updated content to reflect the changes done in eu-regional.dtd and eu-envelope.mod)
|
2. Changes in the Util files
| File* |
Change |
| dtd\eu-envelope.mod |
Update of the version to 3.1
Addition of “Article-18” in the “submission” element
Addition of “re-examination” in the “submission-unit” element
Addition of “xi” in the “env-countries” element |
| dtd\eu-regional.dtd |
Update of the version to 3.1
Addition of “xi” in the “countries” element
Addition of ga” in the “languages” element |
| style\eu-regional.xsl |
Update of the version to 3.1
Update of multiple Agencies names
Addition of “Article-18” for Submission mode
Addition of “re-examination” for Submission-unit mode |
* The other files in the Util package remain unchanged
3. Validation Criteria Version 8.0 - What's new?
Criterion number
in 7.1 |
Criterion number
in 8.0* |
Clarification added in the comment
(The UUID is unique for each Dossier and is identical with the most recent sequence sent)
|
|
9.9
|
9.9
|
Clarification added in the comment
(The UUID is unique for each Dossier and is identical with the most recent sequence sent)
|
|
15.1
|
15.BP1.1
|
Rule changed from P/F to BP and content updated due to the new Annex on the accepted file formats.
(The files provided in the folders for Module 1 are in acceptable formats)
|
|
15.2
|
15.BP2.1
|
Rule changed from P/F to BP and content updated due to the new Annex on the accepted file formats.
(The files provided in the folders for Module 2-5 are in acceptable formats)
|
|
15.BP1
|
15.BP1
|
Content updated (size changed to 500MB)
|
|
-
|
15.BP6 (new)
|
New BP Validation criterion
(Individual video files do not exceed 1GB in size)
|
|
15.11
|
15.11
|
Content changed and rule extended to all procedure types: new P/F check for Tracking table for Centralised Procedures
|
|
15.12
|
15.12
|
Clarification added for the naming on the location of the tracking table files.
|
|
16.3
|
16.3
|
Clarification added for signed documents
(This validation criterion does not apply to and will not reject certified or any other type of digitally signed documents.) |
|
-
|
16.BP11 (new)
|
New BP Validation criterion
(For labelling documents (Module 1.3) the description of the documents is filled in.)
|
|
Picklist values
|
Picklist values
|
Added “xi” for countries and “ga” for languages
|
|
Files and Folders Q&A
|
Files and Folders Q&A
|
Content Updated (removed reference to NeeS)
|
*Version 8.0 contains the draft intermediate versions 7.2 and 7.3
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