The South Korean government is set to support the K-Bio CMC industry, which encompasses the entire process from drug candidate discovery to raw materials, manufacturing, and quality control. The Ministry of Trade, Industry and Energy and the Ministry of Science and ICT plan to jointly develop an open CMC platform to support the entire cycle of new drug development.
On September 29, Deputy Minister Moon Shin-hak attended a seminar on strengthening CMC industry capabilities at the Widen Tower in Pangyo's Second Techno Valley, where he discussed the direction for fostering the pharmaceutical raw materials, manufacturing, and quality control industries.
CMC stands for Chemistry, Manufacturing, and Controls. It is the process of demonstrating to regulatory authorities that a developed drug maintains the same quality and safety from the raw material stage through to manufacturing and market release.
Even if a drug candidate shows efficacy, it requires the design of manufacturing processes, establishment of quality standards, and development of analytical methods to be produced as an actual product. The government recognizes that CMC capabilities are becoming a key competitive advantage in the new drug development and commercialization process.
To enhance the domestic CMC industry, the Ministry of Trade is pursuing a new joint R&D project with the Ministry of Science and ICT. This initiative aims to establish an open CMC platform that individual companies can utilize, providing comprehensive CMC services from candidate optimization to non-clinical and clinical stages.
In addition to R&D, the government will also support the training of specialized personnel and expert consulting. The seminar discussed strategies for strengthening domestic CMC industry capabilities, global market entry strategies, and programs for training CMC professionals.
Beyond CMC, the Ministry is also expanding the transition to artificial intelligence in the bio-manufacturing sector this year. Approximately 23 billion won, or 68% of the new bio program R&D projects, will be prioritized for support in collaborations between bio and AI companies, with a total investment of 145 billion won planned over the next five years.
Deputy Minister Moon stated, "CMC is a core competitive factor that determines the success or failure of new drug development," adding that the government plans to support R&D, personnel training, and expert consulting to secure global competitiveness in the CMC industry.
* This article has been translated by AI.
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