"From Technology Development to Testing"... Trade Ministry, Food and Drug Safety Ministry Join Forces on Bio AI Transformation
Establish Validation Standards and Regulatory Guidelines for New AI Technologies
Also Pursue Localization of Bio Materials, Components, and Equipment and Supply Chain Stabilization
The government will establish a cooperation framework covering the entire process, from technology development and regulatory approval to exports, to accelerate the AI transformation of the bio industry and support the entry of innovative Korean products into global markets.
The Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety said on October 14 that they had signed a “Memorandum of Understanding on the AI Transformation of the Bio Industry and Strengthening Global Competitiveness” at the Chuncheon Bioindustry Foundation in Chuncheon, Gangwon Province.
As AI adoption and the restructuring of global supply chains accelerate change throughout the bio industry, from research and development to manufacturing, quality control, and exports, the Ministry of Trade, Industry and Energy, which is responsible for fostering the bio industry, and the Ministry of Food and Drug Safety, which oversees regulations on pharmaceuticals and medical devices, are setting up a standing cooperation framework to enhance the competitiveness of Korean companies.
Under the agreement, the two organizations will pursue the development, testing, and commercialization of AI convergence technologies in the bio sector; establish validation standards and guidelines for new AI technologies; develop and commercialize Korean-made bio materials, components, and equipment; support exports by sharing information on overseas regulations; and stabilize supply chains for key healthcare products.
They also plan to form a director-general-level consultative body to identify and advance collaborative initiatives, including joint research and development (R&D) projects in “M.AX Bio”—the AI transformation of manufacturing—and in bio materials, components, and equipment, and to review progress.
Minister of Trade, Industry and Energy Kim Jung-kwan said, “There are many steps to complete before bio and medical device technologies reach the market, including demonstrating performance, obtaining regulatory approval, and securing sales channels. The Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety need to work as one team. We will work together to accelerate the AI transformation of the bio industry and deliver tangible results, from technology development to exports.”
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Minister of Food and Drug Safety Oh Yu-kyoung said, “For promising technologies to be adopted quickly in the field, regulatory reviews and the establishment of an institutional foundation must proceed alongside development from the early stages. Building on the regulatory diplomacy expertise we have developed, we will work closely with the Ministry of Trade, Industry and Energy to actively support the rapid market entry of innovative products from Korean companies.”
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