Heads of Global Medicines Regulators Gather in Seoul... First ICMRA Summit in South Korea

Discussing the Future of Global Medicines Regulation

Heads of leading medicines regulatory authorities from around the world are gathering in Seoul to discuss the future of global medicines regulation. Key topics include the use of artificial intelligence (AI) in medicines regulation, new assessment technologies to replace animal testing, and patient-centered drug development.

Oh Yookyung, Commissioner of the Ministry of Food and Drug Safety (left), attends an Executive Committee meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA) at Conrad Seoul in Yeongdeungpo-gu, Seoul, on the 3rd. Ministry of Food and Drug Safety

The Ministry of Food and Drug Safety said on November 4 that it is hosting the summit and plenary of the International Coalition of Medicines Regulatory Authorities (ICMRA) at Conrad Seoul in Yeongdeungpo-gu, Seoul, through November 6.

ICMRA is an international coalition comprising medicines regulatory authorities from 40 member countries, including the United States, the European Union (EU), and Japan, as well as the World Health Organization (WHO). It aims to protect global public health by promoting cooperation among medicines regulatory authorities and coordinated responses to global public health issues. Established in 2013, it was formally launched in November 2015.

This is the first time an ICMRA summit has been held in South Korea. The event is also significant because it follows the Ministry of Food and Drug Safety's election in September as a member of the ICMRA Executive Committee for the 2026-2029 term. The Executive Committee is ICMRA's decision-making body, responsible for determining and overseeing its key activities. Chaired by Australia, it includes 13 regulatory authorities from 11 countries, including the United States, the EU, and Japan.

Representatives of regulatory authorities from 30 countries will attend the event, including Emer Cooke, Executive Director of the European Medicines Agency (EMA), and Yasuhiro Fujiwara, Chief Executive of Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

At the summit on November 4, participants will first share global trends in the use of AI in medicines regulation and explore strategies for applying the technology in actual regulatory settings. The Ministry of Food and Drug Safety will co-chair the session with Singapore's Health Sciences Authority (HSA). The session will be held in conjunction with AIRIS 2026, an international platform for discussing ways to ensure the safe regulatory use of AI-based medical products. The ministry has led related international discussions by co-hosting AIRIS with the U.S. Food and Drug Administration (FDA) in 2024 and with the WHO last year.

The second session will discuss promoting new approach methodologies (NAMs) and establishing next-generation regulatory frameworks. Participants will explore ways to build a next-generation regulatory system that uses emerging technologies such as AI and organoids to replace or reduce animal testing and more accurately predict and assess human responses. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Japan's PMDA will co-chair the session.

Participants will also discuss patient-centered drug development and regulatory frameworks. The EMA and Poland's Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) will co-chair the session and explore ways to improve drug development and regulatory systems from the patient's perspective.

During the summit, the Ministry of Food and Drug Safety will also hold separate bilateral meetings with regulatory authorities from key countries, including the EMA and Australia's Therapeutic Goods Administration (TGA). Building on mutual regulatory trust, the meetings will address practical areas of cooperation, including joint reviews and exchanges of medicines regulatory information.

Oh Yugyeong, Minister of Food and Drug Safety, said, "The Seoul summit is a meaningful opportunity for South Korea, as both an Executive Committee member and the host country, to take the lead on global medicines regulatory issues. We will use this opportunity to bring together heads of leading regulatory authorities around the world as a platform for strategic regulatory diplomacy centered on the national interest, and build a practical foundation for cooperation that will support domestic pharmaceutical and biotech companies' entry into global markets."

This content was produced with the assistance of AI translation services.