The Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety are building a cooperation framework covering the full cycle of artificial intelligence in the biotechnology sector, from technology development through licensing to exports. The plan links the industry ministry's support for technology development and commercialization with the food and drug ministry's regulatory capabilities to speed market entry for AI-converged bio technologies and domestically made materials, parts and equipment.
The two agencies said they will sign a memorandum of understanding on the artificial intelligence transformation of the bio industry and the strengthening of its global competitiveness at the Chuncheon Bioindustry Foundation in Gangwon State on the 14th. The agencies said the spread of AI and the realignment of global supply chains are reshaping development, manufacturing, quality control and exports across the bio industry, increasing the need to pursue technology development and regulatory support together.
The two agencies will first provide joint support for the development, testing and commercialization of AI-converged technologies in the bio sector. They also agreed to establish verification standards and guidelines for AI technologies so that new technologies can lead to actual products. The aim is for the industry ministry to support technology development while the food and drug ministry takes part in reviews from a regulatory perspective from the early stages of development, reducing regulatory uncertainty that can arise as products move toward the market.
The agencies will also cooperate on the development and commercialization of domestic bio materials, parts and equipment. They will support commercialization so that domestically developed bio materials, parts and equipment can be applied at actual industrial sites, while sharing overseas regulatory information to back exports by domestic companies. They will also pursue cooperation to stabilize the supply chain for key health care items.
The two agencies plan to run the agreement as a standing cooperation framework rather than a one-off project. They will launch a director-general-level consultative body to identify joint research and development projects in the bio materials, parts and equipment sector and under M.AX Bio, a program driving the AI transformation of bio manufacturing processes, and to review progress.
"Bio and medical device technologies must clear many stages before reaching the market, including performance verification, licensing and securing sales channels, so the industry ministry and the Ministry of Food and Drug Safety need to move as one team," Industry Minister Kim Jung-kwan said. "We will cooperate to accelerate the AI transformation of the bio industry and to produce tangible results from technology development through to exports."
"For excellent technologies to be introduced quickly in the field, reviews from a regulatory perspective and the creation of an institutional foundation must proceed in parallel from the early stages of development," MFDS Commissioner Oh Yu-kyoung said. "Based on the regulatory diplomacy expertise the ministry has built up, we will support our companies so their innovative products can enter the market quickly."