On the occasion of the state visit of President Yoon Suk Yeol, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) met with Dr. Robert M. Califf, Commissioner of the US Food and Drug Administration (FDA) to discuss cooperation between the two organizations in the field of digital health and signed a Memorandum of Cooperation (MOC*) on April 27 (local time) to strengthen cooperation on medical products using artificial intelligence (AI).
The signing of the MOC is part of the strengthening of cooperation in the Korea-U.S. high-tech alliance and supports the core and emerging technology cooperation agreed upon by the two leaders. It was also promoted as a follow-up to the meeting between Minister Oh Yu-Kyoung and Commissioner Robert Califf in March.
Specifically, it was designed to ▲ share experiences in using AI for medical product development ▲ discuss ways to promote the use of innovative technologies to develop effective and safe medical products ▲ and promote the harmonization of medical product regulations using AI, which is jointly led by the MFDS and the US FDA.
AI technology, which has been rapidly developing in recent years, is increasingly being utilized in the field of medical product development. In particular, with the advent of the borderless digital era based on the cloud, regulatory agencies in each country agree on the need for international harmonization of the regulatory system to promote the development of medical products using AI technology and support their rapid use on site.
Against this backdrop, the signing of the MOC is significant as both organizations have recognized the importance of international harmonization in the digital health sector and have taken the first step for considering and discussing together to activate the development of medical products using AI technology.
Building on the signing of this MOC, the two organizations will hold joint workshops to share experiences in using AI for medical product development with regulators from around the world and discuss how regulators can help advance the use of innovative technologies to deliver safe and effective medical products.
MFDS will continue and develop in-depth discussions with the US FDA based on the joint workshop so that the results of the joint workshop can be used as a global standard. Based on this, we will strengthen regulatory support to revitalize the development and export of medical products using AI, such as refining the system more rationally and taking initiative in setting guidelines.
Prior to this, on April 26 (local time), Minister Oh visited WellDoc, a US-based company that received approval for its digital therapeutics for the first time in the world. She shared her views on recent global market trends and future development directions in the digital health sector.
In addition, on April 26 (local time), the Minister attended the '2023 APEC Medical Product Supply Chain Dialogue' event at the United States Pharmacopeia (USP), where she shared Korea's best policy practices for the pharmaceutical supply chain. She also discussed with USP representative Dr. Ronald Piervincenzi ways to actively cooperate with each other, including ways to promote joint research on innovative medicines and human resource exchange.
The visit laid the groundwork for concrete and practical cooperation with the US FDA and USP in the field of medical products. MFDS will continue to expand cooperation on issues of common interest, such as clinical trials and food safety management. The Korea Medical Devices Industry Association and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association commented on the bilateral cooperation that they welcome the MFDS’ advanced regulatory science activities and international harmonization efforts to support Korean companies' initiatives in overseas markets.
MFDS will spare no efforts to expand our role on the global stage through multifaceted cooperation with food and drug regulatory agencies around the world. The Ministry will proactively prepare regulations for medical products applied with innovative future technologies so that Korea's regulations can soon become a global regulatory standard.