With the new South Korean government under President Suk-Yeol Yoon designating the pharma and biotech industry as one of the most promising national sectors and aiming to grow the country into a major player in global markets, companies and the market are so far viewing the incoming People Power Party administration as more pro-industry compared to its predecessors.
Will Korea's New Government Create Strong Biohealth Nation?
Focus On Single 'Control Tower,' Rapid Reimbursement
The health-related policies of South Korea's new government and how they may affect the pharma industry were dissected at a recent forum in Seoul.
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letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.