Policy & Regulation
First Public-Private Pharmaceutical Industry Innovation Council Launched ‘Semi-Innovative Pharmaceutical Company’ Designation to Be Introduced, With Legal Basis Planned by Year-End

The government has launched a public-private council to strengthen the competitiveness of the pharmaceutical industry and foster innovative pharmaceutical companies.
The Ministry of Health and Welfare said it formed the first Pharmaceutical Industry Innovation Public-Private Council and held its inaugural meeting at 3:30 p.m. on the 2nd at the Koreana Hotel in Seoul.
The council is co-chaired by Lee Hyung-hoon, second vice minister of health and welfare, and Noh Yeon-hong, president of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. It comprises 21 members, including representatives of relevant government ministries, stakeholders, experts and public institutions.
The council plans to discuss measures to foster innovative and semi-innovative pharmaceutical companies; strengthen the management and oversight of contract sales organizations (CSOs); help companies focused on generic drugs grow, specialize and become exporters; promote development of biologic new drugs, improved drugs and natural product drugs; and advance drug development using artificial intelligence (AI) and manufacturing innovation.
At its first meeting, the council discussed its formation and operating procedures, improvements to the innovative pharmaceutical company certification system and plans for new certifications, as well as plans to designate and operate semi-innovative pharmaceutical companies.
In July, the Ministry of Health and Welfare revised subordinate regulations under the Special Act on the Promotion and Support of the Pharmaceutical Industry, updating the certification system by strengthening research and development (R&D) investment criteria for innovative pharmaceutical companies and rationalizing rebate-related certification requirements.
Applications for new certifications in the second half of 2026 are being accepted from Aug. 18 through Sept. 18. Following a review, the Pharmaceutical Industry Promotion and Support Committee will make a final decision and announce the certifications in December.
The ministry will introduce a “semi-innovative pharmaceutical company” designation to support promising small and midsize and venture pharmaceutical companies that invest at least a certain level in R&D. Designated companies will receive preferential pricing for generic drugs. The ministry plans to establish a legal basis by year-end and then begin accepting new applications.
Second Vice Minister Lee Hyung-hoon said, “I hope this council will share the current state of Korea’s pharmaceutical industry and, through vigorous discussion, develop directions for fostering and advancing the industry to drive future growth.”
Association President Noh Yeon-hong said, “I hope the views put forward by pharmaceutical and biotech companies will be fully reflected and help create an opportunity for development across the pharmaceutical and biotech ecosystem, including R&D and product manufacturing.”

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