ICH Singapore Meeting" was held.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) will meet in Singapore from November 15 to 19, 2025. The meeting was held in Singapore from November 15 to 19, 2025. During the meeting, in addition to the Assembly, which was attended by all ICH members and observers, a Management Committee meeting was held to discuss matters for the Assembly. During the same period, the 12 topic working groups responsible for ICH guideline development held expert meetings, and through active discussions, progress was made in the development of guidelines for each topic. The year 2025 marks the 35th anniversary of the establishment of ICH (April 1990) and the 10th anniversary of the establishment of the ICH Association as a non-profit corporation (2015). The year 2025 also marks the 35th anniversary of the establishment of ICH (April 1990) and the 10th anniversary of the establishment of ICH Association as a non-profit corporation (2015). Japan's Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and the JPMA have participated in the development of the guidelines since ICH's inception and have contributed to the promotion of international harmonization as founding organizations.

Overall view of the Assembly

In principle, ICH meetings are face-to-face meetings, and approximately 500 committee members and experts from around the world gathered in Singapore, where the meeting was held. The meeting was attended by six industry-government organizations from the EU, Japan, the U.S., and the U.S.A., all of which are founding members of the ICH. ¹ 2 Standing Members ² 17 member organizations ³ Standing Observers: 2 organizations ⁴ and 29 observer organizations. Twenty-seven JPMA members, including those from the Assembly, Management Committee, and experts from the Working Groups, traveled to Singapore to participate in the meeting.

The following are special notes based on the ICH Management Committee and ICH Assembly 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 ICH observer organizations, the Dominican Republic's Drug and Food Safety Products Regulatory Agency (DIGEMAPS) and the Food and Drug Administration of the Republic of the Philippines' Department of Health (Philippine FDA), submitted applications that were both approved by the Assembly and granted membership to the ICH.

As a result, the number of members increased by 25 organizations (2 more) and observers by 41 organizations (no increase or decrease), bringing the overall organizational structure of ICH to 66 organizations (see the reference material at the end of this report).

2．Trends in ICH Technical Topics

The ICH Singapore meeting was attended by 12 Topic Working Groups in conjunction with the Assembly. The groups usually hold regular web-based meetings, but this was an opportunity for intensive discussions over four or five days of face-to-face meetings to make progress in the development of the guidelines.

Working Groups with Meetings

During the meeting, the M11 Guideline was approved by the Assembly and reached Step 4, and the English version of the ICH Guideline was completed. The draft technical document for E22 was also approved by the Assembly and reached Step 2. The Assembly also discussed the progress of all active topics and identified topics that have reached major milestones since the May 2025 ICH Madrid meeting. The following is a summary of the topics where milestones have been reached.

Topics reached in Step 4

Topics reached in Step 2

3. Newly active topics

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

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

The term of the Chair and Vice-Chair of the ICH Assembly and Management Committee expired, and elections were held at the Singapore meeting. As a result of the election, Mr. Daisuke Koga, Director of International Affairs Department, PMDA, was elected as the Chair of the ICH Management Committee, the first time that a Chair has been appointed from Japan to the ICH.

5. Election of Chair and Vice-Chair of MedDRA Steering Committee (MedDRA Steering Committee)

ICH has developed and continues to maintain MedDRA. At this meeting, elections were held for the Chair and Vice-Chair of the MedDRA Steering Committee. The election resulted in the election of Ana Cochino (EC) as Chair and Charlotte James (MHRA) as Vice-Chair.

6. ICH Award

The ICH Awards are presented to experts who have demonstrated leadership and made significant contributions to the development of the ICH Guidelines. The third ICH Awards ceremony was held at the Assembly. The industry side recipient was JPMA safety domain expert Masayuki Mishima, formerly of the Drug Evaluation Committee, who was recognized for his important leadership and sustained contributions to the ICH Expert Working Group.

What trophies were brought back to Japan?
The trophy, which was brought back to Japan, was presented by Mr. Yoshida, Managing Director of ICH Project, during the ICH Project Committee meeting.

Mr. Mishima with the award trophy

Next ICH Meeting

The meeting will be held 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)

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