The Digital Health Sector Also Embraces the 'Hanmi Alliance'... Establishing Global Standards

South Korea and the United States are launching an advanced technology alliance to establish global standards for promoting the development of AI-powered medical products. The Ministry of Food and Drug Safety (MFDS) announced on the 2nd that it signed a Memorandum of Cooperation (MOC) containing this agreement with Robert Califf, Commissioner of the U.S. Food and Drug Administration (FDA), on the 27th of last month (local time).

Robert Califf, Commissioner of the U.S. Food and Drug Administration (FDA), and Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, are signing a memorandum of understanding and taking a commemorative photo.
[Photo by Ministry of Food and Drug Safety]

This agreement was pursued to establish regulatory harmonization for AI-powered medical products jointly led by the MFDS and the FDA. Recently, rapidly advancing AI technology is increasingly being utilized in the field of medical product development. Accordingly, the need for international harmonization of regulatory systems has grown to support the swift development and commercialization of AI-powered medical products.

The Memorandum of Cooperation contains provisions supporting core and emerging technology cooperation agreed upon by the heads of state of South Korea and the U.S. This is a follow-up to discussions between MFDS Commissioner Eo Yu-kyung and FDA Commissioner Califf in March, marking the 70th anniversary of the Korea-U.S. alliance, regarding the development of guidelines and regulatory innovation for innovative products such as digital therapeutics. Specifically, they agreed to share experiences in utilizing AI for medical product development and to discuss ways to promote the use of innovative technologies.

The MFDS plans to ensure that this advanced technology alliance with the FDA can be used as an international standard in the digital health sector. Based on this, they will rationally organize the system and proactively establish guidelines to activate the development and export of AI-powered medical products.

The Korea Medical Devices Industry Association and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association expressed their “welcome” for this bilateral cooperation. An MFDS official stated, “We will continue to make every effort through multifaceted cooperation with overseas food and drug regulatory agencies to ensure that South Korea’s regulations become global regulatory standards on the international stage.”