“ICH Rio de Janeiro Meeting” Held ~ The First ICH Meeting Held in South America ~

A meeting of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was held in Rio de Janeiro, Brazil, from May 30 to June 3, 2026.During the meeting, the Assembly—composed of all ICH members and observers—and the Management Committee, which deliberates on matters to be submitted to the Assembly, were convened.In addition, meetings of the MedDRA (Medical Dictionary for Regulatory Activities) Steering Committee and working groups on 12 technical topics were held, and discussions progressed toward the development of various guidelines. Furthermore, key milestones were achieved, such as E6(R3) Annex 2 reaching Step 4.

This meeting marked the first time the ICH had convened in South America. In the host country, Brazil, the Brazilian Health Regulatory Agency (ANVISA) actively participates in international regulatory harmonization activities as an ICH member, making this meeting a symbol of further progress in regulatory harmonization in the South American region.

ICH meetings are generally held in person, and this time as well, approximately 500 committee members and experts from countries and regions around the world gathered in Rio de Janeiro.In addition to the six industry and government organizations from Japan, the U.S., and the EU—which are founding members—two permanent regulatory authority members, 17 other members, two Standing Observers, and 25 other observers attended, leading to lively discussions. Twenty-six representatives from the JPMA, including officials from the Assembly and the Management Committee as well as experts from working groups, participated in person.

Key Outcomes of the ICH Assembly and Management Committee

Admission of New Members and Observers

At this Assembly, new applications for ICH observer status from the Drug Regulatory Authority of Pakistan (DRAP) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) were approved. There were no applications for promotion to full membership.

As a result, ICH now comprises a total of 68 organizations: 25 member organizations and 43 observer organizations.

Formulation of the ICH Strategic Vision

At this meeting, the “ICH Strategic Vision,” which outlines ICH’s mission, its contribution to public health, and its approach to promoting rapid access to medicines, was approved.It includes five strategic priorities to be focused on over the next five years (2026–2030) and serves as a key document outlining ICH’s future direction. The “ICH Strategic Vision” is available on the official ICH website.

ICH Strategic Vision

Publication of the Technology Task Force Final Report

The Technology Task Force has been exploring the development of a secure information-sharing platform to support the harmonized development and consistent implementation of ICH guidelines. At this meeting, the final recommendation regarding the establishment of a single commercial cloud-based platform compliant with Swiss law was reported to the Assembly, and the publication of the final report on the official ICH website was approved.The final report is available on the official ICH website.

Technology Task Force Final Report: ICH Technology Platform Technical Capabilities and Requirements

Progress on Technical Topics

12 working groups held in-person meetings

Working groups on 12 technical topics gathered at the ICH Rio de Janeiro meeting. While each group typically conducts its activities primarily through regular web conferences, at this meeting they held intensive in-person discussions over four to five days to advance their guideline development work.

In particular, the Q5E Annex EWG is a new working group established in February 2026, building on discussions held by its predecessor, the ICH Cell and Gene Therapy Discussion Group (CGTDG). This was the group’s first in-person meeting, during which it began full-scale deliberations toward guideline development, including the drafting of a concept paper.

List of Working Groups That Held Meetings

E6(R3) Annex 2 Reaches Step 4

At this meeting, Annex 2 of the ICH E6(R3) Guideline for Good Clinical Practice was adopted by the regulatory members of the Assembly, marking the achievement of Step 4—a significant milestone for the ICH.This marks the completion of the series of revisions to E6(R3).

In addition, topics that had reached major milestones since the ICH meeting in Singapore in November 2025 were reviewed.

Topics for Which Key Milestones Have Been Reached

Next Meeting

The next ICH meeting is scheduled to take place in Prague, Czech Republic, from November 14 to 18, 2026.

Conclusion

The ICH actively publishes the outcomes of its meetings and the progress of each technical topic. For details on each topic, including concept papers and work plans—such as the outcomes of this ICH meeting in Rio de Janeiro—please refer to the official ICH website.

ICH Official Website

Reference Material: List of ICH Members and Observers (as of June 2026)

Table 1: List of Members (25 Organizations)

Table 2: List of Observers (43 Organizations)

(Mariko Kato, Director, International Regulatory Coordination Division)

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