Policy & Regulation
First meeting of the Pharmaceutical Industry Innovation Public-Private Council held New semi-innovative pharmaceutical company designation to be introduced, with legal basis planned by year-end

The government is launching the Pharmaceutical Industry Innovation Public-Private Council, bringing together relevant ministries, industry and experts, to strengthen the competitiveness of the pharmaceutical industry and foster innovative pharmaceutical companies.
The Ministry of Health and Welfare said it formed the council and held its first meeting at 3:30 p.m. on the 2nd at the Koreana Hotel in Seoul.
The council has Lee Hyeong-hun, second vice minister of health and welfare, and Noh Yeon-hong, president of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, as co-chairs. It comprises 21 members from relevant ministries, public institutions, related associations, the pharmaceutical and biotech industries, and expert groups.
The meeting covered plans to foster innovative and semi-innovative pharmaceutical companies; strengthen oversight of contract sales organizations (CSOs); help companies focused on generic drugs grow in scale and specialize; promote the development of biopharmaceuticals; and advance drug development using artificial intelligence (AI).
In July, the ministry revised the certification system for innovative pharmaceutical companies through amendments to the subordinate regulations of the Special Act on the Promotion and Support of the Pharmaceutical Industry. The revisions strengthened research and development (R&D) investment criteria, rationalized certification requirements related to rebates, and established a separate certification category for foreign pharmaceutical companies.
Applications for new certifications in the second half of 2026 will be accepted from the 18th of last month through the 18th of this month. Following a review, the Pharmaceutical Industry Promotion and Support Committee is expected to make a final decision and issue a public notice in December.
The ministry will also introduce a “semi-innovative pharmaceutical company” designation to support promising small and midsize pharmaceutical and biotech companies. The plan is to designate companies that invest at least a specified level in R&D, offer them preferential pricing for generic drugs, and establish a stepwise development pathway from “startup to semi-innovative company to innovative company to globally competitive pharmaceutical company.”
The ministry plans to establish a legal basis for the semi-innovative pharmaceutical company designation by year-end, then begin accepting new applications.
Vice Minister Lee said, “I hope the council will share the current state of Korea’s pharmaceutical industry and, through vigorous discussion, develop a direction for fostering and advancing the industry that will drive its growth.”
Association President Noh said, “I hope the views put forward by pharmaceutical and biotech companies will be fully reflected and help create an opportunity for progress across the industry ecosystem, including R&D and product manufacturing.”

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