Category CMDh updates

Last updated: 29 November 2025 To view updates, click on the ‘+’ sign below. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure – FAQ updated Here you can view the track changed (15 July 2025) and…

Last updated: 27 September 2025 To view updates, click on the ‘+’ sign below. Paediatric-use marketing authorisations The Application process section on this page of the EMA website has been updated. Source: EMA IRIS guide to registration and Research Product Identifiers…

Last updated: 27 August 2025 To view updates, click on the ‘+’ sign below. eCTD v4.0- Controlled Vocabularies v2 (genericode format) now available eCTD v4.0 technical pilot phase 2 update Source: eSubmission PLM Portal eAF – FHIR 2.2.5 – planned…

Last updated: 14 August 2025 To view updates, click on the ‘+’ sign below. PLM Portal FHIR XML version upgrade The PLM portal FHIR XML version was updated to 2.2.3. The new version introduces the following changes: • There’s a new…

Last updated: 23 June 2025 To view updates, click on the ‘+’ sign below. Report and minutes from the CMDh meeting held on 20-21 May 2025 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of…

Last updated: 28 April 2025 To view updates, click on the ‘+’ sign below eAF v1.27.0.1 (Human Variation) now available, for use from 1 May 2025 A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website.…

Last updated: 31 March 2025 To view updates, click on the ‘+’ sign below: Update – MedEthicsEU report – Survey on National Part II Clinical Trial Application (CTA) requirements (March 2025) Overview part II requirements in a Clinical Trial application…