Heads of Global Medicines Regulatory Authorities Gather in Seoul... Discuss AI Trends

MFDS to Host First ICMRA Summit in Korea, Nov. 3-6
30 Countries, Including the U.S. FDA and EMA, to Attend

Heads of major medicines regulatory authorities from around the world will gather in Seoul to discuss trends in artificial intelligence (AI) in regulation and other topics.

The Ministry of Food and Drug Safety said it will host the summit and general assembly of the International Coalition of Medicines Regulatory Authorities (ICMRA) at Conrad Seoul in Yeongdeungpo-gu, Seoul, from November 3 to 6.

ICMRA is a coalition of medicines regulatory authorities with 40 member countries, including the United States, the European Union (EU), and Japan, as well as the World Health Organization (WHO). This is the first time an ICMRA summit has been held in Korea. In September this year, the Ministry of Food and Drug Safety was elected to the ICMRA Executive Committee, its decision-making body.

Officials from medicines regulatory authorities in 30 countries will attend the meeting, including representatives of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

The main agenda items include global trends in AI for medicines regulation and practical implementation strategies; promoting new approaches using AI and organoids and establishing regulatory frameworks; and strengthening patient-centered medicines development and regulatory frameworks.

The Ministry of Food and Drug Safety will co-chair some sessions with Singapore's Health Sciences Authority (HSA). During the event, MFDS Commissioner Oh Yookyung will hold bilateral meetings with the heads of regulatory authorities in major countries, including the EMA and Australia's Therapeutic Goods Administration (TGA). They will discuss practical regulatory cooperation, including joint reviews based on mutual regulatory reliance and the exchange of medicines regulatory information.

Commissioner Oh said, "This summit is a meaningful opportunity for Korea to lead discussions on global medicines regulatory issues as an Executive Committee member and host country. We will use this gathering of leaders from major regulatory authorities around the world as a platform for strategic regulatory diplomacy focused on the national interest, and build a practical foundation for cooperation to support Korean pharmaceutical and biotech companies as they expand into global markets."

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