The Assembly of the International Council for Harmonisation (ICH) met in-person on 5 & 6 November 2024, in Montréal, Canada. This meeting was held in parallel to meetings of 11 Working Groups and 1 Discussion Group, and preceded by meetings of the ICH Management Committee (MC) and the MedDRA MC. The Assembly was chaired by Lenita Lindström (EC, Europe, ICH Assembly Chair) and Dr Gabriela Zenhäusern (Swissmedic, Switzerland, ICH Assembly Vice-Chair).
ICH continues to expand and welcomed with great pleasure CPPS, Uzbekistan, DIGEMID, Peru and Thai FDA, Thailand as new ICH Observers, bringing ICH to a total of 23 Members and 38 Observers.
Monitoring ICH Guideline Implementation
As monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus, the Assembly welcomed the publication in October 2024 on the ICH website of the results of the recent survey conducted in 2024, building on the previous 2019 and 2021 assessments. The main objectives of this survey were to monitor progress of international harmonisation, identify regulatory training and capacity building needs, assist the ICH MC in determining whether the Regulatory Members would meet the eligibility criteria for the June 2024 ICH MC elections, and allow participating Observers interested in future ICH Membership to reference the survey findings to confirm their eligibility.
Progress on ICH Guideline Development and Important Revisions
At the Montréal meeting, the Assembly endorsed the following Guidelines by consensus:
- The ICH M13A Guideline and associated Questions and Answers (Q&As) on “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” reached Step 4 of the ICH Process prior to the Montréal, Canada meeting on 23 July 2024. This Guideline provides recommendations on conducting bioequivalence studies during both development and post-approval phases for orally administered, immediate-release, solid oral dosage forms. The Q&As document is intended to provide additional clarification and improve harmonisation of bioequivalence study design and data analysis.
- The ICH E11A Guideline on “Pediatric Extrapolation” reached Step 4 of the ICH Process prior to the Montréal, Canada meeting on 21 August 2024. The E11A Guideline provides a framework for using extrapolation to support paediatric drug development.
When guidelines are endorsed by consensus within the ICH organisation (Step 4), they are regarded as harmonised and therefore as “documents that reflect the current state of science and technology” (see Swissmedic Journal 05/2006, p. 504).
Progress on ICH Guideline Development
- The Draft ICH E6(R3) Annex 2 Guideline on “Good Clinical Practice (GCP)” reached Step 2a/b and was endorsed by the ICH Assembly. This Annex addresses the GCP considerations that arise from the increased use of a wider range of design elements and data sources, and focuses on examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD).
- The Draft ICH M15 Guideline on “General Principles for Model-Informed Drug Development (MIDD)” reached Step 2a/b and was endorsed by the ICH Assembly. The overarching Guideline is expected to cover the general principles and good practices for the use of MIDD.
The next ICH Assembly meeting is scheduled to be held on 13 and 14 May 2025 in Madrid, Spain.
Further information can be found in the ICH press release: ICH website