eSubmission: Updates of 'Validation Criteria'

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

For medicinal products for human use, the so-called 'electronic Common Technical Document (eCTD)' is used as the standard for dossier submissions. It consists of five modules (modules 1-5). In the middle of the year, a number of updates were published for this, as you could already read under EMA: Update of Module 1. Now, further updates have been published on the EMA's eSubmission website.

Validation criteria

The list of 'Validation Criteria' has been updated so that it is now available in version 8.1. The 'Release notes for version 8.1 of the EU eCTD M1 Validation Criteria (minor correction)' list the new features of the document in the usual manner and emphasise the differences compared to the previous version 8.0. The introduction and transition periods for use have been set for 01 December 2024 for versions v7.1, 8.0 or v8.1. From 01 March 2025, version 8.1 of the 'Validation Criteria' is mandatory.

The information of the updated passages can be found here.