The EMA introduced a major update to the EU eCTD Module 1 specifications and validation criteria last year. After a transition period that began on December 1, 2024, the use of EU M1 v3.1 and validation criteria v8.1 will become mandatory on March 1, 2025 – so now is the time to prepare!
Here are the most important changes you need to know:
- UK Country Code: The country code “uk” can no longer be used in EU submissions due to Brexit. For Northern Ireland, a new code “xi” has been introduced.
- Accepted File Formats: While PDF is the primary format for eCTD submissions, some alternative formats will be exceptionally accepted, for instance certain image formats for for mock-up documents or text files for clinical study data sets.
- Irish Language Code: The language code “ga” (for Irish) has been added to the official list.
- Envelope Updates: A new submission type and submission unit option have been added, respectively Article-18 and Re-examination.
- Clarifications: Additional guidance has been provided, e.g. on handling missing eCTD sections, avoiding re-submissions, and the correct use of “closing” and “consolidating” submission units.
If you’re handling eCTD submissions in the EU, make sure your software is updated before March 1st and that your team is trained on the new Module 1 specifications.
Need support or have any eCTD-related questions? Get in touch at [email protected] and our team is happy to help!
