A new year may have dawned, but South Korea remains engulfed in a political crisis stemming from a failed martial law attempt in early December which has led to the opposition-controlled parliament’s impeachment of both President Suk-Yeol Yoon and Acting President Duck-Soo Han in less than a month.
2024 Korea Regulatory Highlights And What’s In Store For This Year
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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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.
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A short-lived but shocking attempt to declare martial law by South Korea's president has thrown the country into political turmoil which could disrupt foreign biopharma investment and key policy initiatives.
More from Pink Sheet Perspectives
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The inspector general said the council should be more involved in specific approval decisions when there is internal disagreement, but FDA said that would preclude some individuals from adjudicating a subsequent withdrawal proceeding.
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Two recent accelerated approval guidances describe the FDA’s policy expectations for trial timeliness, but recognize the need for case-specific determinations. Regulatory actions in 2024 show the FDA is willing to delay application filing or approval over confirmatory trial status.
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While Japan looks set to further improve policies to support ventures and ease market entry this year, these will contrast with ongoing reimbursement price controls.