The ICH E6(R3) Annex 2 draft Guideline on Good Clinical Practice reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period.

Panzyga and associated names (human normal immunoglobin (IVIg))End of procedure: 04/10/2024Date of publication: 25/11/2024

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.

Template request for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008 (October 2024) [Track version]