ICH Montreal Meeting" was held.

January 14, 2025

The International Conference on Harmonization of Pharmaceutical Regulations (ICH) meeting was held in Montreal, Canada, from November 2 to 6, 2024. The meeting included a General Assembly attended by all ICH members, as well as a Management Committee meeting to prepare proposals to be discussed at the General Assembly and to review the operation 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 General Assembly, reaching Step 2, an important milestone in the ICH.

General Meeting 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 permanent members (Health Canada and Swissmedic), and 15 member organizations² 2 permanent 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 people from the Pharmaceutical Manufacturers Association of Japan (PMAJ), 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 National Agency for Health Supervision (ANVISA), Argentinean National Agency for Medicines, Food and Medical Technology (ANMAT), Mexican Federal Commission for Sanitary Risk Control (COFEPRIS), Egyptian authorities (EDA), Health Sciences Authority of Singapore (HAS), Jordan Food and Drug Administration (JFDA), Korea Food and Drug Safety Agency (MFDS), UK Pharmaceuticals and Medical Products Administration (JPMA) (MFDS), UK Medicines and Healthcare products Regulatory Agency (MHRA), China National Medicines Regulatory Administration (NMPA), Saudi Food and Drug Administration (SFDA), Taiwan Food and Drug Administration (TFDA), Turkish Institute for Medicines and Medical Devices (TITCK), Biotechnology Innovation Institute (BIO), Global Self Care Federation (GSCF), International Federation (GSCF), International Generic and Biosimilar Pharmaceuticals 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 the ICH General Assembly at the Montreal meeting. 1.

New members and observers

Three organizations have applied to be new ICH observers: the Uzbekistan regulatory authority (CPPS), the Peruvian regulatory authority (DIGEMID), and the Thai regulatory authority (Thai FDA). All of the regulatory authorities were approved at the ICH General Assembly and admitted to ICH membership. There were no applications from ICH observers to become ICH members.

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

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 on the development of the guidelines.

Working and discussion groups that met

Q1/Q5C EWG: Revision of "Guidelines for Stability Studies of Pharmaceutical Products
Q3E EWG: Guidelines for Extractables and Eluates of Pharmaceuticals
Q6(R1) EWG: Revision of "Establishment of Specifications and Test Methods for Pharmaceuticals
E2D(R1) EWG: Post-approval safety information: Definitions and criteria for handling and reporting individual case safety reports
E6(R3) EWG: Revision of "Criteria for Conducting Clinical Studies on Drugs
E21 EWG: Inclusion of Pregnant and Lactating Women in Clinical Trials
E22 EWG: General Considerations for Patient Preference Trials
M2 EWG: Electronic Standards for the Transmission of Drug Regulatory Information
M4Q(R2) EWG: Revision of the Common Technical Documents - Guidelines for Quality Documentation
M11 EWG: Electronically Structured and Harmonized Clinical Trial Protocols
M13 EWG: Bioequivalence Studies of Immediate Release Oral Solid Dosage Forms
CGTDG: Cell and Gene Therapy Discussion Group

During this meeting, the draft technical documents for E6(R3) and M15 were approved by the ICH General 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 meeting, is expected to reach Step 4 by the middle of 2025, and the GCP renewal process will finally begin in earnest.

Topics that have reached Step 4

M13A: Bioequivalence Study of Immediate-release Oral Solid Dosage Forms (July 2024)
E11A: Extrapolation in Pediatric Drug Development (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: Guidelines for standards for the conduct of clinical trials for pharmaceutical products Annex 2 (ICH General Assembly, November 2024)
M15: Model-Informed Drug Development (ICH General 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 each year before being decided by the ICH General Assembly, 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 a priority. 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 this survey, which includes monitoring the progress of international harmonization and identifying training and capacity building needs of regulators, is to determine the eligibility criteria for ICH elected MC elections at the last meeting in June 2024 (ICH Fukuoka meeting), as well as 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, in order 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/ ).