"ICH Montreal Meeting" to Be Held

November 2, 2024

A meeting of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was held in Montreal, Canada, from November 2 to 6, 2024.In addition to the Assembly, which was attended by all ICH members, the meeting included sessions of the Management Committee and other bodies that discussed preparations for items to be proposed and debated at the Assembly, as well as ICH operations. During the same period, meetings on 12 topics were held in parallel, bringing experts from various fields to Montreal.At this meeting, discussions on ICH technical guidelines and progress on specific guideline documents continued. In particular, draft technical documents for two topics were approved at the ICH Assembly, reaching Step 2—a significant milestone for the ICH.

Group photo of the Assembly
The participating organizations at the ICH Montreal meeting consisted of six industry and government bodies from Japan, the U.S., and the EU—all founding members^*1 , two Standing Members (Health Canada and Swissmedic), and 15 member organizations^*2 , and two Standing Observers^*3 , and 17 observer organizations. ICH meetings are generally held in person; more than 500 people from around the world gathered in Montreal, the host city, and 28 representatives from the JPMA, including experts from working groups, attended in person.

*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, 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),the 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)

The following are notable points based on the ICH Management Committee and ICH Assembly meetings held in Montreal.

１．New members and observers

Applications for new ICH observer status were received from three organizations: the Uzbek regulatory authority (CPPS), the Peruvian regulatory authority (DIGEMID), and the Thai regulatory authority (Thai FDA). All three regulatory authorities were approved at the ICH Assembly and granted observer status with ICH.Note that there were no applications for promotion from ICH Observer to ICH Member status at this meeting.

As a result, the number of ICH Members remains at 23 (no change), while the number of Observers has increased by 3 to 38, bringing the total number of organizations within ICH to 61 (see reference materials at the end).

２．Trends in ICH Technical Topics

At this meeting, 11 expert working groups and one discussion group convened. While each group typically holds regular web conferences, they took this opportunity to meet in person for four or five days of intensive sessions, engaging in extensive discussions to advance progress on guideline development.

Working Groups and Discussion Groups that Held Meetings

Q1/Q5C EWG: Revision of Stability Testing Guidelines for Drugs
Q3E EWG: Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products
Q6(R1) Informal WG: Revision of the Specifications Guidelines
E2D(R1) EWG: Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
E6(R3) EWG: Revision of "Good Clinical Practice" for the Conduct of Clinical Trials of Medicinal Products
E21 informal WG: Inclusion of pregnant and breastfeeding individuals in clinical trials
E22：General Considerations for Patient Preference Studies
M2：Eectronic Standards for the Transfer of Regulatory Information
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
CGTDG: Cell and Gene Therapy Discussion Group

During this session, the draft technical documents for E6(R3) and M15 were approved at the ICH Assembly, reaching Step 2—a major milestone within the ICH process.Furthermore, in the six months following the ICH Fukuoka meeting in June 2024, M13A and E11A reached Step 4, and the respective ICH guidelines (English versions) were finalized.

In particular, regarding E6(R3), the comprehensive GCP principles and Annex 1—which form the core of the guideline—are now on the verge of reaching Step 4.Furthermore, Annex 2 (GCP for Non-Conventional Intervention Trials), which reached Step 2 at this Assembly, is expected to reach Step 4 by mid-2025, marking the start of full-scale efforts to overhaul GCP.

Topics that have reached Step 4

M13A EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms (July 2024)
E11A: Pediatric Extrapolation (August 2024)
(Reaching Step 4 means that the draft guideline has been finally agreed upon and adopted by regulatory representatives at the ICH Assembly, and the English version of the guideline has been finalized. The implementation process by regulatory authorities in each region and country will now begin.)

Topics that have reached Step 2

E6(R3) Annex 2: Guideline for Good Clinical Practice (Annex 2)
M15: Model-Informed Drug Development (November 2024 ICH Assembly)
(Reaching Step 2 means that the draft guideline based on the technical document has been approved by regulatory representatives at the ICH Assembly, and the process will now move to Step 3, during which regulatory authorities in each region and country will conduct public comment periods.)

3. ICH Operations

As the number of ICH members and observers has expanded, ICH activities have diversified in recent years, and discussions to overhaul ICH operations into a sustainable framework have been underway since the spring of 2024. Discussions will continue regarding the modernization of the ICH Secretariat’s operations—including organizational structure and procedural manuals—as well as portfolio management.

4. Process for Reviewing New Topics for 2025

New ICH topics are decided at the ICH Assembly each year following review by the ICH Management Committee. Discussions regarding the 2025 review process took into account factors such as the number of currently active working groups and the status of topics scheduled to be prioritized for launch in the future.As a result, it was decided that the selection of new topics for 2025 would proceed through the standard process, subject to certain constraints—such as a limit of three proposals per organization and the requirement that each proposal be supported by at least two organizations (including the proposer).

5. ICH Implementation Status Survey

ICH commissions an external organization (CIRS) to survey the implementation status of ICH guidelines in member countries and regions.Surveys were previously conducted in 2019 and 2021, and the most recent survey was carried out in 2024. The primary objectives of this survey are to monitor the progress of international harmonization and to identify the training and capacity-building needs of regulatory authorities; however,it is also used to determine whether regulatory authority members meet the eligibility criteria for the ICH-elected MC election held at the previous meeting in June 2024 (the ICH Fukuoka Meeting). Reports on these survey results are all published on the ICH website, and the latest results from 2024 were released in October 2024.

6. Next ICH Meeting

The meeting is scheduled to take place in Madrid, Spain, from May 10 to 14, 2025.

Furthermore, ICH actively publishes information regarding 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 Montreal meeting, as well as concept papers and work plans for each topic, are available on the ICH website ( https://www.ich.org/ ).