The “ICH Singapore Meeting” is being held

A meeting of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was held in Singapore from November 15 to 19, 2025.During the meeting, in addition to the Assembly attended by all ICH members and observers, a Management Committee meeting was held to discuss items on the Assembly agenda. Also during this period, the 12 topic-specific working groups responsible for developing ICH guidelines held expert meetings, and through lively discussions, progress was made on drafting guidelines for each topic.As a result, the M11 guideline was finalized and reached Step 4, while the draft technical document for E22 was approved and reached Step 2, marking major milestones for ICH.The year 2025 marks the 35th anniversary of the ICH’s inception (April 1990) and the 10th anniversary of the establishment of the ICH Association as a nonprofit organization (2015).Japan’s Ministry of Health, Labor and Welfare, the Pharmaceuticals and Medical Devices Agency (PMDA), and the JPMA have participated in the development of guidelines since the ICH’s inception and, as founding members, have contributed to the promotion of international harmonization.

Group photo of the Assembly

ICH meetings are generally held in person, and approximately 500 committee members and experts from around the world gathered in Singapore, the host city. Six industry and government organizations from Japan, the U.S., and the EU—all founding members—participated in this meeting. ^*1 , as well as two Standing Members ^*2 , and 17 member organizations ^※3 , 2 Standing Observers ^*4 , and 29 observer organizations participated. Twenty-seven representatives from the JPMA—including officials from the Assembly and Management Committee, as well as experts from working groups—traveled to Singapore, the host city, to attend the meeting.

The following outlines specific points based on the ICH Management Committee and ICH Assembly meetings held at the ICH Singapore Meeting.

1．Admission of new members and observers

Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) and the South African Health Products Regulatory Authority (SAHPRA) applied for promotion to new ICH members. Both applications were approved at the ICH Assembly, granting them membership in the ICH.

In addition, two new organizations—the Directorate General for the Regulation of Medicines, Food, and Sanitary Products of the Dominican Republic (DIGEMAPS) and the Food and Drug Administration of the Republic of the Philippines (Philippine FDA)—applied for observer status with ICH. Both applications were approved at the Assembly, and their membership in ICH was granted.

As a result, the number of members stands at 25 organizations (an increase of 2), and the number of observers remains at 41 (no change), bringing the total number of organizations within ICH to 66 (see reference materials at the end).

2．Trends in ICH Technical Topics

At the ICH Singapore Meeting, working groups for 12 topics convened in conjunction with the Assembly. While each group typically holds regular web conferences, they took this opportunity to engage in intensive discussions during four- or five-day in-person meetings to advance progress on guideline development.

Working Groups That Held Meetings

During this session, the M11 guideline was approved by the Assembly, reaching Step 4, and the English version of the ICH guideline was finalized. Additionally, the draft technical document for E22 was approved by the Assembly, reaching Step 2.Furthermore, at this Assembly, progress on all active topics was discussed, and topics that had reached major milestones since the ICH Madrid meeting in May 2025 were confirmed. The topics that have reached milestones are summarized below.

Topics that have reached Step 4

Topics that have reached Step 2

3. Developments on Newly Launched Topics

Regarding the following two topics adopted at the ICH Madrid meeting in May 2025, concept papers were approved, and the respective working groups will begin drafting technical documents.

4. ICH Assembly/Management Committee: Election of Chair and Vice-Chair

As the terms of office for the Chair and Vice-Chair of the ICH Assembly and Management Committee had expired, elections were held during the Singapore meeting. As a result of the election, Daisuke Koga, Director of the International Planning Department at the PMDA, was elected Chair of the ICH Management Committee. This marks the first time a Chair from Japan has been appointed to an ICH position.

5. Election of the Chair and Vice Chair of the MedDRA Steering Committee

While ICH develops and continuously maintains MedDRA, elections for the Chair and Vice Chair of the MedDRA Steering Committee were held at this meeting. As a result of the election, Ana Cochino (EC) was elected Chair and Charlotte James (MHRA) was elected Vice Chair.

6. ICH Awards

The “ICH Award” is presented to experts who have demonstrated leadership and made significant contributions to the development of ICH guidelines. For this third edition, five experts were selected based on nominations from various organizations, and the ICH Award ceremony was held during the Assembly.Two recipients from Japan were honored: one from the regulatory authority and one from the industry. The industry recipient was Mr. Masayuki Mishima, a safety expert at the JPMA (formerly a member of the Drug Evaluation Committee), who was recognized for his significant leadership and sustained contributions to the ICH Expert Working Groups.

The trophy brought back to Japan was presented by Executive Director Yoshida during the
ICH Project Committee meeting.

Mr. Mishima holding his award trophy

Next ICH Meeting

The meeting is scheduled to take place in Rio de Janeiro, Brazil, from May 30 to June 3, 2026.

[Reference: List of ICH Members and Observers (as of November 2025)]

Table 1: Members (25 organizations)

Table 2: Observers (41 organizations)

(Mariko Kato, Director, International Regulatory Coordination Division)

Back to ICH Project Announcements for 2025

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