Meeting of a subgroup of CMDh with Interested Parties dedicated to the publication of outcomes of safety variations - 14 November 2024 MinutesPresentationsSafety Variation Example

The ICH Q13 IWG “Continuous Manufacturing of Drug Substances and Drug Products” Video Training Material Modules 1-12 are now available on the ICH Website.

An updated draft timeline for the implementation of eCTD v4.0 in the EU is now available on the eCTD v4.0 page here.

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to the portal made in releases on 14th November 2022 and on 28th November 2022 are now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.

The Assembly of the International Council for Harmonisation (ICH) met in-person on 5 & 6 November 2024, in Montréal, Canada in parallel of meetings of 11 Working Groups and 1 Discussion Group, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.

The ICH Secretariat is pleased to announce the publication of the updated training materials related to ICH Q9(R1) Quality Risk Management (QRM).

The ICH Secretariat is pleased to announce the publication of ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video.

EMA/CMDh Explanatory notes on variation application form (Human medicinal products only) (November 2024) [Track version]

Added in July 2025 01 July UPDATE - SOP on the processing of PSUR single assessment for nationally authorised productsUPDATE - Data requested for New Applications in the MRP/DCPUPDATE - Data requested for Variations and/or Renewal Applications in the MRP/DCPUPDATE - Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National ProceduresUPDATE [...]

LEGAL FRAMEWORK Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use (Variation Regulation) has entered into force on 7 July 2024. It became applicable on 1 January 2025. This regulation revised the rules setting [...]