Last updated: 12 June 2025
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Updated PLM Portal eAF Release notes now available
An updated version of the Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.6 released to production on 10 June 2025 are now available on PLM Portal and on the PLM Portal eAF web page
eCTD 3.2.2 – new package available
New versions of the following have now been published:
- EU eCTD M1 Specification, version 3.1.1 has been published on the eSubmission website . The version 3.1.1 sees the introduction of a small number of changes in the specification, related to the tracking table for EDQM and new examples of product numbers and procedure numbers for work-sharing and super-grouping. The changes are reflected in the Release Notes .
- Validation criteria v8.2 has been published on the eSubmission website. The version 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 1 December 2025 to the NCAs and EMA. The changes are reflected in the Release Notes.
- Harmonised guidance eCTD 6.0.1 has been published together with the new version of the specification and the validation criteria
Note: The Util files remain the same
- During the initial period of 4 months from 2 June 2025 to 30 September 2025, applicants can only submit eCTD format submissions compliant with EU M1 v3.1 and validation criteria version 8.1.
- From 1 October 2025 eCTDs compliant with EU M1 v3.1 or v3.1.1 and validation criteria v8.1 or v8.2 are accepted.
- From 1 December 2025 only eCTDs compliant with EU M1 v3.1.1 and validation criteria v8.2 are accepted.
Source: eSubmission