The government is establishing a comprehensive support system for the bioindustry's transition to artificial intelligence (AI), covering everything from technology development to product validation, regulatory approval, and overseas exports. The Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety are setting up a permanent collaboration framework to support the commercialization of new technologies.
On October 14, the two ministries signed a memorandum of understanding (MOU) at the Chuncheon Bioindustry Promotion Center in Gangwon Province to enhance the AI transition in the bioindustry and strengthen its global competitiveness. This agreement was made in response to the rapidly changing competitive landscape of the bioindustry due to the spread of AI technology and the restructuring of global supply chains.
Bio products must go through several stages, including technology development, performance verification, regulatory approval, and securing distribution channels before they can be launched in the market. To proactively secure competitiveness, regulatory support that aligns with technological advancements is essential.
As part of this initiative, the two ministries will first strengthen cooperation in the development, validation, and commercialization of AI convergence technologies in the bio sector. They plan to jointly establish verification standards and guidelines to ensure that new AI technologies can be applied to actual products.
Support will also be provided for the development and commercialization of domestic bio materials, components, and equipment. The Ministry of Trade, Industry and Energy will link its technology development support with the regulatory expertise of the Ministry of Food and Drug Safety to ensure that research and development outcomes lead to actual products.
Additionally, support for entering overseas markets will be expanded. The two ministries will share information on foreign regulations and enhance regulatory services needed for domestic bio companies during the export process. They will also promote cooperation to stabilize the supply chains of key healthcare products, including pharmaceuticals and medical devices.
Following the MOU, a director-level consultative body will be established to identify specific joint projects. Discussions will include the application of M.AX, which signifies the AI transition in manufacturing, to the bio sector and collaborative research and development (R&D) projects in bio materials, components, and equipment.
Last year, the Ministry of Food and Drug Safety established guidelines for the approval and review of generative AI medical devices in line with the implementation of the Digital Medical Products Act. In April of this year, it also provided guidelines related to clinical trials for digital medical devices, demonstrating its commitment to regulatory support. This MOU is significant as it aligns with the Ministry of Trade, Industry and Energy's policies on technology development and commercialization.
Kim Jeong-kwan, Minister of Trade, Industry and Energy, stated, "There are many stages that bio and medical device technologies must go through before reaching the market, including performance verification, regulatory approval, and securing distribution channels. Therefore, the Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety must work as one team. We will collaborate to accelerate the AI transition in the bio industry and ensure tangible results from technology development to export."
Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, emphasized, "To ensure that excellent technologies are swiftly introduced to the field, regulatory considerations and the establishment of institutional foundations must be addressed from the early stages of development. The Ministry of Food and Drug Safety will actively support our companies' innovative products to enter the market quickly, leveraging the regulatory diplomacy expertise we have built over the years."
* This article has been translated by AI.
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