South Korea is aggressively fostering its biopharma and health-related sectors, looking to grow these into national flagship strategic industries. The country is seen to have outstanding talent in the area, along with strong information and communications technologies to support medical data-based innovation.
Korea’s Powerhouse Ambitions Build On Innovation-Fostering Policies
Financing Late-Stage Trials 'Biggest Obstacle'
South Korea’s Second Vice Minister of Health and Welfare Minsoo Park talks to the Pink Sheet about a broad range of issues including the government’s priorities for innovative R&D, as well as challenges in reaching these goals, measures to deal with the deterioration in biopharma investment sentiment and regulatory changes to support drug development.
More from South Korea
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.
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In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.
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The Pink Sheet looks at what major policies and regulations South Korean authorities prioritized in 2024 and what may be in store for this year.
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Speedier approval of clinical trials, flexibility towards new technologies, faster access to new drugs and lingering regulatory barriers to decentralized trials are among the challenges South Korea is facing in becoming a global trial hot spot.
More from Asia
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A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.
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Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
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While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.