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 Cover letter for the submission of variation applications in the MRP (October 2024) [Track version]
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 [...]
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 Recognition Procedures for Variations (October 2024) [...]
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 [...]
Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 (October 2024) [Track version]