The EU eCTD Module 1 Specification has been updated to v3.1.
EU M1 eCTD Specification v3.1 – Updated Guidelines: Release notes with practical information on changes are provided below. There are also changes to the DTD in this version (version 3.1), and the validation criteria was updated to v8.0 (release notes are also published).
During the initial period of 6 months from 18 June 2024 to 30 November 2024, applicants can only submit eCTD format submissions compliant with EU M1 v3.0.4 and validation criteria version 7.1.
From 1 December 2024 eCTDs compliant with EU M1 v3.0.4 or v3.1 and validation criteria v7.1 or v8.0 are accepted.
From 1 March 2025 only eCTDs compliant with EU M1 v3.1 and validation criteria v8.0 are accepted.
| EU M1 v3.1 | |
| Status | Approved |
| (Optional use from 1 December 2024) | |
| Mandatory use from 1 March 2025 | |
| Release Notes | View Specification Release Notes |
| Specification | View June 2024 |
| Annex | View |
| Accepted file formats | Accepted file formats May 2024 |
| DTD | v.3.1 |
| Examples | |
| Package | Download – June 2024 |
| Implementation Guide | Download |
| Checksum of | |
| eu-regional.dtd | f8e473246d58499f9ffff8e51a32380d |
| eu-envelope.mod | cf059a8f48c68fe4ce9ad2947ab854ca |
| eu-leaf.mod | 23b854174e61c68044b9f53c0009af95 |
| eu-regional.xsl | 474f3fe1fdadb31c74477793e060383d |