Korea, US agencies call for global regulatory standards on AI-assisted medical product development

Overseas regulatory agencies will be invited to workshops jointly hosted by the Korean MFDS and the US FDA.

Korea’s Ministry of Food and Drug Safety and the US Food and Drug Administration teamed up to promote the use of artificial intelligence (AI) in medical product development with a goal of setting the global standard for regulation.

The two organizations signed a memorandum of cooperation to share experiences and promote the use of AI for medical product development according to a government statement on 5 May.

They also called for a more harmonized regulatory system in the digital healthcare sector among the international community to boost growth.

The Korean and American agencies will jointly conduct workshops with regulators across the world to discuss how authorities can help advance the use of tech in producing safe and effective medical products.

The results of the workshops can then be used to form the global regulatory standards covering the manufacture of medical products using AI.

“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,” the statement read.

Korea’s MFDS said it also plans to broaden its cooperation with the US FDA further and potentially cover common programs between the two organizations, like clinical trials and food safety management.