Category CMDh updates

Last updated: 13 August 2026 To view updates, click on the ‘+’ sign below. Reminder: mandatory use of PLM web-based eAF for CAPs – 1 September 2026 As announced in April 2026, the European Medicines Agency (EMA) is introducing the…

Last updated on 30 July 2026 To view updates, click on the ‘+’ sign below. Templates variation assessment report Here, you can view the track changed (Mar 2026) and clean (Jul 2026) versions of the document Type II variation Preliminary-Final…

Last updated: 1 July 2026 To view updates, click on the + sign below: IRIS guide for applicants updated The above guide on how to create, submit and manage IRIS applications, centralised product contacts for industry and individual applicants was…

Last updated: 30 April 2026 To view updates, click on the ‘+’ sign below. Clinical Trial Information System (CTIS) – Sponsor Frequently Asked Questions (FAQ) The CTIS Sponsor Frequently Asked Questions (FAQ) is based on questions frequently raised by sponsors during CTIS events such as walk-in clinics, bitesize…

Last updated: 5 May 2026 To view updates, click on the ‘+’ sign below: Updated EU Commission Q&A guidance on EU Clinical Trials Regulation (CTR) and revised versions of several Clinical Trials Coordination Group (CTCG) templates An updated version (v7.2…

Last updated: 5 March 2026 To view updates, click on the ‘+’ sign below. Plasma Master File (PMF) requirements. Questions and Answers for PMF Holders This Q&A was updated on 19 January 2026 due to Editorial deletion of Section Alert…

Last updated 27 February 2026 To view updates, click on the ‘+’ sign below. Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers (Final document) This document: Source: IMDRF List of…

Last updated: 3 February 2026 To view updates, click on the ‘+’ sign below. The worksharing procedure for the assessment of Active Substance Master File (ASMF) The document with the above title has been updated. Here, you can view the…

Last updated: 18 December 2025 To view updates, click on the ‘+’ sign below. Highlights from the Clinical Trials Coordination Group (CTCG) plenary meeting On  3–4 November 2025, CTCG met at EMA to discuss initiatives aimed at streamlining clinical trial…