Topics "ICH Fukuoka Meeting" Held

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A meeting of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was held in Fukuoka from June 1 to 5, 2024. While ICH meetings rotate among Europe, the Americas, and Asia, this was the first time in six years—since the ICH Kobe Meeting in June 2018—that the event was held in Japan.

Group Photo from the Assembly Group Photo from the Assembly

In addition to the Assembly, which was attended by all ICH members, the meeting also featured sessions of the Management Committee and other bodies that prepared the agenda for the Assembly and discussed ICH operations.In addition, 13 expert working groups met in parallel during the same period to review ICH technical guidelines and advance the development of specific guideline documents. ICH meetings, held twice a year, are generally conducted with in-person participation as the standard.

The breakdown of participating organizations at the Fukuoka meeting was as follows: six industry and government organizations*1 from Japan, the U.S., and the EU (the founding members); two Standing Members (Health Canada and Swissmedic); 15 member organizations*2; two Standing Observers*3; and 17 observers.More than 500 people from around the world gathered for the Fukuoka meeting, and 35 representatives from the JPMA, including experts from working groups, attended in person.

The following outlines notable points from the ICH Management Committee and ICH Assembly held at the Fukuoka Meeting.

*1

U.S. Food and Drug Administration (FDA), European Commission/European Medicines Agency (EC/EMA), Ministry of Health, Labor and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Japan Pharmaceutical Manufacturers Association (JPMA)
*2

Brazilian Health Regulatory Agency (ANVISA), Argentina National Superintendence of Medicines, Food and Medical Technology（ANMAT), Federal Commission for Protection against Sanitary Risks (COFEPRIS) Mexico, the Egyptian Drug Authority (EDA), Singapore Health Sciences Authority (HAS), Jordan Food and Drug Administration (JFDA), Korea Ministry of Food and Drug Safety (MFDS), UK Medicines and Healthcare products Regulatory Agency (MHRA), National Medical Products Administration (NMPA) Chinathe Saudi Food and Drug Authority (SFDA), the Taiwan Food and Drug Administration (TFDA), the Turkish Medicines and Medical Devices Agency (TITCK), the Biotechnology Innovation Organization(BIO), the Global Self-Care Federation (GSCF), and the International Generic and Biosimilar Medicines Association (IGBA)
*3

International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), World Health Organization (WHO)

1. New Members and Observers

Two organizations—The Argentinean authorities (Argentine National Administration of Drugs, Food and Medical Devices, (ANMAT)) and the Jordanian authorities (Jordan Food and Drug Authority, JFDA)—applied for promotion to full ICH membership. Both were approved at the ICH Assembly and granted membership in ICH.There were no applications for new ICH observer status this time.

As a result, the number of ICH members stands at 23 and the number of observers at 35, bringing the total number of organizations within the ICH to 58 (see the reference materials at the end of this document).

2. Trends in ICH Technical Topics

Working Groups That Held Meetings

At the Fukuoka meeting, working groups for all 13 topics convened. Each working group engaged in intensive discussions over four or five days, making progress on the development of guidelines.
　

•	Q1/Q5C EWG: Revision of Stability Testing Guidelines for Drugs
•	Q2 (R2)/Q14 EWG: Revision of "Validation of Analytical Procedure" and "Analytical Procedure Development"
•	Q3E EWG: Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products
•	Q5A (R2) IWG: Revision of “Quality of Biopharmaceuticals: Viral Validation”
•	Q6(R1) Informal WG: Revision of the Specifications Guidelines
•	Q9(R1): Rivision of "Quality Risk Management"
•	E6 (R3) EWG: Revision of "Good Clinical Practice"
•	E20 EWG: Adaptive Clinical Trials
•	E21 informal WG: Inclusion of pregnant and breastfeeding individuals in clinical trials
•	M4Q(R2)EWG: Revision of the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
•	M11 EWG: Clinical electronic Structured Harmonised Protocol (CeSHarP)
•	M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
•	M15 EWG: General Principles for Model-Informed Drug Development

Topics That Reached Key Milestones

Although no topics reached a step transition during the Fukuoka meeting, the following topics reached important milestones within the ICH over the six months following the ICH Prague meeting in November 2023.
　

•	M12: Drug Interaction Studies (Reached Step 4 in May 2024)
•	M14：General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines (Reached Step 2 in May 2024)
•	E2D(R1): Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports(Reached Step 2 in February 2024)

*Reaching Step 2 means that a draft guideline based on technical documents has been approved by regulatory authority representatives at the Assembly, and the process will now move to Step 3, during which regulatory authorities in each region and country will conduct public comment periods.Reaching Step 4 means that the draft guideline has been finally agreed upon and adopted by regulatory authority representatives at the Assembly, and the English version of the guideline has been finalized. The implementation process will now begin at regulatory authorities in each region and country.

3. Election of ICH Management Committee Members

The ICH Management Committee consists of Founding Members (3 regulatory authorities, 3 industry representatives), Standing Members (2 regulatory authorities), Standing Observers (WHO, IFPMA), and Elected Representatives (4 regulatory authorities, 2 industry representatives). Among these, the Elected Representatives are re-elected every three years, and the election was held this time.As a result of the election, the following organizations were selected as members of the Management Committee:
　

Regulatory Authorities:	Brazilian Health Regulatory Agency (ANVISA), Ministry of Food and Drug Safety of South Korea (MFDS), National Medical Products Administration (NMPA), Saudi Food and Drug Authority (SFDA)
Industry: Biotechnology Innovation Organization(BIO), International Generic and Biosimilar Medicines Association (IGBA)

4. Adoption of New Topics

The following topics were adopted as new areas for future guideline development. The specific start dates for these activities will be determined at a later date.
　

•	ICH M7 Guideline Addendum "Risk Assessment and Control of Nitrosamine Impurities"

5. Adoption of ICH Reflection Paper

At the Fukuoka meeting, a revised version of the reflection paper titled “International Harmonization of Terminology for Real-World Evidence (RWE) Focused on the Efficacy of Medicinal Products and Integration of General Principles for the Design and Reporting of Studies Using Real-World Data (RWD)” was reviewed and adopted at the ICH Assembly.

6. Next ICH Meeting

The meeting is scheduled to be held in Montreal, Canada, from November 2 to 6, 2024.

ICH actively publishes information on its activities, including the outcomes of ICH meetings, to promote a deeper understanding not only among stakeholders but also among the general public. The outcomes of this ICH Fukuoka Meeting, as well as concept papers and work plans for each topic, are available on the ICH website ( https://www.ich.org/ ).