EMA: Update of Module 1
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For human medicinal products, the so-called "electronic Common Technical Document (eCTD)" is the standard for dossier applications. It consists of five modules (modules 1-5). The following changes to Module 1 were published in the middle of this year.
EU Module 1 eCTD Specification (Version 3.1)
In June 2024, the updated version of the "EU Module 1 eCTD Specification (Version 3.1)" was published on EMA's eSubmission website. This version contains a large number of revisions and updates, which are listed both in the document's change history and in the so-called "release notes" entitled "Release notes for version 3.1 of the EU eCTD M1 Specification (major update) June 2024" on the eSubmission website.
Validation criteria
The "Validation criteria" have also been updated so that they are now available in version 8.0. The "Release notes for version 8.0 of the EU eCTD M1 Validation Criteria (major update) June 2024" also lists the new features of the document and clearly highlights the differences compared to the previous version 7.1.
The introduction and transition periods for using the new versions are listed in detail on the eSubmission website and should be fully completed by the end of March 2025.
Information on the updated Module 1 passages can be found here.
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