Policy & Regulation
Ministries hear policy needs at meeting with biopharma startups and SMEs Plan calls for end-to-end drug development support and cross-ministry growth framework

The Ministry of SMEs and Startups and the Ministry of Health and Welfare are developing policies to provide focused support for promising small and midsize biopharma companies and startups.
The two ministries said they shared key elements of the “K-Biopharma Frontier Company Development Plan” at a meeting with biopharma startups and SMEs on the 17th at Lunit Inc. in Gangnam-gu, Seoul.
The meeting was held to incorporate companies’ challenges and policy needs into a development plan the ministries are preparing jointly to respond to the rapidly changing global biopharma market and secure future growth drivers.
Attendees included First Vice Minister of SMEs and Startups Noh Yong-seok and Second Vice Minister of Health and Welfare Lee Hyeong-hun, along with representatives of eight startups and SMEs in drug development, digital health and medical devices, and biomaterials and manufacturing technology.
The ministries discussed ways to coordinate research and development (R&D), clinical, investment and commercialization support across the entire drug development process, from candidate discovery through nonclinical testing, clinical trials, regulatory approval and commercialization.
Participants said support for technology development, testing and validation is needed during candidate development and the nonclinical stage, while large-scale funding, specialized personnel, and collaboration with hospitals and clinical institutions become increasingly important as programs advance to clinical trials.
Participants also said policy coordination should be strengthened to sustain growth after clinical trials, through regulatory approval, technology transfer, follow-on investment and entry into global markets.
The ministries plan to identify promising startups and SMEs with growth potential and technological capabilities, and establish a system to coordinate and provide policy support based on each company’s stage of growth and needs.
In particular, they plan to flesh out the development plan by coordinating the ministries’ policy tools around a growth pathway from technology development through clinical trials and validation, commercialization, investment and guarantees, and global expansion, rather than limiting support to individual R&D projects.
In March, the ministries jointly announced a “Full-Cycle Collaboration Plan for Biopharma Ventures” to address challenges at each stage of growth for biopharma startups.
“Even when a company has promising drug candidates and technology, biopharma is a field that requires considerable time and funding to reach the market through clinical trials and commercialization,” First Vice Minister Noh Yong-seok said. “By combining the Ministry of SMEs and Startups’ capabilities in R&D, investment and commercialization with the Ministry of Health and Welfare’s biopharma expertise, we will actively support promising companies as they grow and enter global markets.”
“Working closely with the Ministry of SMEs and Startups and drawing on the voices of companies, we will establish an effective support system to address the challenges promising companies face as they grow,” Second Vice Minister Lee Hyeong-hun said.

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