Panzyga and associated names…
Panzyga and associated names (human normal immunoglobin (IVIg))End of procedure: 04/10/2024Date of publication: 25/11/2024
ICH Q13 IWG Video Training Material Modules 1-12 are now available on the ICH Website
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.
Updated draft eCTD v4.0 implementation timeline for EU now available
An updated draft timeline for the implementation of eCTD v4.0 in the EU is now available on the eCTD v4.0 page here.
Updated PLM Portal eAF Release notes now available
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.
Press Release: ICH Assembly Meeting, Montréal, Canada, November 2024
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.
ICH Q9(R1) IWG Updated Training Materials
The ICH Secretariat is pleased to announce the publication of the updated training materials related to ICH Q9(R1) Quality Risk Management (QRM).
ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video now available on the ICH Website
The ICH Secretariat is pleased to announce the publication of ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video.
Guidance applicable from 1 January…
Guidance applicable from 1 January 2025 Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition ProcedureChapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II Variations, Grouping and Worksharing (October 2024) [Track version]Chapter 2: Procedure for Automatic Validation of Mutual [...]
Q&A – List for the submission of…
Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 (October 2024) [Track version]
Guidance is available on the…
Guidance is available on the implementation of the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted from 1 January 2025. This guidance provides instructions on the implementation of the amended Variations Regulation applicable as of 1 January 2025 that includes amendments to the Article 5 procedure, on the annual update for minor [...]