ICH Montreal Meeting" was held.

November 02, 2024

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) held its meeting in Montreal, Canada, from November 2 to 6, 2024. The meeting included a Assembly attended by all ICH members, as well as Management Committee meetings to prepare proposals for discussion at the Assembly and to review the management of the ICH. During the same period, 12 parallel Topic Meetings were also held and experts gathered in Montreal. The meeting also discussed ICH technical guidelines and made progress on specific guideline documents. In two topics in particular, draft technical documents were approved by the ICH Assembly, reaching Step 2, an important milestone for the ICH.

Assembly photo
The ICH Montreal meeting was attended by six industry-government organizations from Japan, the U.S., and the EU, which are the founding members of the ICH Montreal meeting.¹ 2 Standing Members (Health Canada and Swissmedic), and 15 Member Organizations² 2 Standing Observers³ In principle, ICH meetings are face-to-face meetings, and more than 500 people from around the world attended the meeting in Montreal. 28 JPMA members, including experts from the Working Groups, participated in the meeting.

1

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

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

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

The following are special notes based on the ICH Management Committee and ICH Assembly at the Montreal meeting.

１．New members and observers

Three new ICH observer organizations have applied for ICH observer status: Uzbekistan (CPPS), Peru (DIGEMID), and Thailand (Thai FDA). All of the regulatory authorities were approved by the ICH Assembly for membership in the ICH. There were no applications from ICH observers to become ICH members.

As a result, there were 23 ICH members (no increase or decrease) and 38 observers (3 increase), bringing the total number of ICH members to 61 (see the reference material at the end of this report).

２．Trends in ICH Technical Topics

Eleven expert working groups and one discussion group met at this meeting. The groups usually hold regular web meetings, but this was an opportunity to meet intensively face-to-face for four or five days to discuss and make progress in the development of the guidelines.

Working and discussion groups that met

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"
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 by the ICH Assembly, reaching Step 2, an important milestone on the ICH. In the six months following the ICH Fukuoka meeting in June 2024, M13A and E11A also reached Step 4 and the ICH Guidelines (English version) were completed, respectively.

In particular, E6 (R3), the overarching GCP principles and Annex 1, which form the main body of the guideline, are on track to reach Step 4 soon. In addition, Annex 2 (GCP for unconventional interventional studies), which reached Step 2 at this Assembly, is also expected to reach Step 4 by the middle of 2025, and the GCP renewal process will finally begin to move into full swing.

Topics that have reached Step 4

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

Topics that have reached Step 2

E6(R3) Annex 2: Guideline for Good Clinical Practice (Annex 2) (ICH Assembly, November 2024)
M15: Model-Informed Drug Development (ICH Assembly, November 2024)
(Reaching Step 2 means that the draft guideline based on the technical document has been approved by the regulatory delegates at the ICH Assembly and will now move to Step 3 where it will be publicly commented on by the regional and national regulatory authorities).

3. ICH Administration

As the number of ICH members and observers has been increasing, ICH activities have been diversifying in recent years, and discussions have been underway since the spring of 2024 to revamp ICH operations into a sustainable structure. Modernization of the ICH Secretariat's operations, including the development of organizational structure and procedures, and portfolio management, will continue to be discussed in the future.

4. 2025 New Topic Review Process

New topics for ICH are discussed by the ICH Management Committee and decided by the ICH Assembly every year, and the process for 2025 was also discussed, taking into account the number of working groups currently in operation and the status of topics that will be initiated as priorities. As a result, it was decided that the selection of new topics for 2025 will be considered through the normal process, with certain restrictions, such as a limit of three proposals per organization and the support of 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 each member country/region. The latest survey was conducted in 2024. The main purpose of the survey is to monitor progress in international harmonization, identify regulatory training and capacity building needs, etc. The survey was conducted at the last meeting (ICH Fukuoka meeting) in June 2024, and the eligibility criteria for ICH elected MC elections were used by the regulators The reports on these findings will be used to determine whether all members have met the eligibility criteria for ICH-elected MC elections. All reports on the results of these surveys are available on the ICH website, and the latest results for 2024 were published in October 2024.

6. Next ICH Meeting

The next ICH meeting is scheduled for May 10-14, 2025, in Madrid, Spain.

ICH actively discloses information on its activities, including the results of the ICH meetings, to deepen understanding of ICH activities among the general public as well as the relevant parties. The outcomes of this ICH Montreal meeting, concept papers on each topic, work plans, etc. are available on the ICH website ( https://www.ich.org/ ).