Last updated: 14 March 2026
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EU eCTD v4.0 validation criteria v1.1 published
Following the consultation period, the final version of the EU eCTD v4.0 Validation Criteria v1.1 is now available.
- The file includes the updated set of rules as well as a separate spreadsheet that highlights all changes and the file structure and names recommendation.
- eCTD v4.0 tool vendors may now begin implementing the new rules, and the updated validation criteria will become applicable starting 15 July 2026.
For any concerns, recommendations or questions, please send an email to ectd4consultation@ema.europa.eu.
The EMA team, together with the EU eCTD v4.0 Subject Matter Experts, will centralise and analyse the requests, and if considered valid, will include them in the following version of the validation criteria.
Reminder
- Applicants are invited to submit new Marketing Authorisation Applications (MAAs) for Centrally Authorised Products (CAPs) in eCTD v4.0 format.
- To ensure that enhanced support is provided and that the assessment team is aware, applicants must contact the EMA eCTD v4.0 team (eCTD4consultation@ema.europa.eu) prior to any eCTD v4.0 submission.
Source: eSubmission
Report from the CMDh meeting held on 24-25 February 2026
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
Acronyms and abbreviations used in the report and minutes are available here.
The report from the above meeting includes (but js not restricted to) the following items):
1. Update of overview of biological active substances of nonrecombinant origin
The CMDh agreed an update of the overview of biological active substances of non recombinant origin.
- The document has been transferred into excel format, simplified and updated with biological active substances of non-recombinant origin, which have been authorised since the last update. You can view it here.
- The overview has previously been accessible via a link from the CMDh Q&As on biologicals.
- To increase visibility, the CMDh agreed to publish the updated document directly on the CMDh website under “Questions and Answers”.
2. MRP/DCP statistics in 2025
You can view the slide deck with Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures in 2025 here.
3. New applications in the MRP and DCP started in January 2026
At this link you can view the stats (tabulated on pages 3 and 4 of the report) as bar charts.
Reminder – New variation classification in eAF
The updated Variation Regulation Classification Guideline has been made available in both the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.
Users are reminded to verify the accuracy and content of the selected scopes (including the conditions and documentation), before submitting the form to the relevant health authorities. In case of any discrepancies, a ticket should be raised Request RMS Service – Employee Center
List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
You can view the list here.