The Assembly of the International Council for Harmonisation (ICH) met in-person on 4 and 5 June 2024, in Fukuoka, Japan, in parallel to meetings of 13 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. The Assembly was chaired by Lenita Lindström (EC, Europe, ICH Assembly Chair) and Dr Gabriela Zenhäusern (Swissmedic, Switzerland, ICH Assembly Vice-Chair).
The ICH continues to expand and welcomed ANMAT, Argentina, and JFDA, Jordan, as new ICH Members, bringing the ICH to a total of 23 Members and 35 Observers.
ICH Management Committee Elections
New elections for a three-year term were held for Elected Representatives to the ICH Management Committee, welcoming Representatives from Regulatory Members: ANVISA, Brazil; MFDS, Republic of Korea; NMPA, China; and SFDA, Saudi Arabia, and Industry Members: BIO and IGBA.
Results of new Implementation Survey
Results of the third ICH Implementation Survey showed the current level of implementation and adherence to ICH Guidelines within Regulatory Member and Observer countries/regions. The survey results demonstrate good progress made by Regulatory Authorities in implementing ICH Guidelines since the two previous surveys in 2019 and 2021.
New Areas of ICH Harmonisation, Reflection Paper
At the Fukuoka meeting, the Assembly adopted a new topic for harmonisation and a revised ICH Reflection Paper:
- An Addendum to the Multidisciplinary Guideline M7 on “Assessment and Control of DNA Reactive (mutagenic) Impurities”
- The revised ICH Reflection Paper on “Pursuing Opportunities for Harmonisation in Using Real-World Data to Generate Real-World Evidence, with a Focus on Effectiveness of Medicines”
Progress on ICH Guideline Development
- The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” was endorsed (at Step 2 of the ICH process) in February 2024.
- The ICH M14 draft Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines” was endorsed (at Step 2 of the ICH process) just prior to the Fukuoka meeting in May 2024.
- The Final ICH M12 Guideline on “Drug Interaction Studies” and supporting M12 Questions and Answers (Q&As) were adopted by consensus (at Step 4 of the ICH Process) just prior to the Fukuoka meeting in May 2024.
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).
The next ICH Assembly meeting is scheduled on 5 and 6 November 2024 in Montreal, Canada.
Further information can be found in the ICH press release: