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South Korea MFDS Drug Registration: 2026 Updates and Approval Guide
This episode explores the significant 2026 updates to the Ministry of Food and Drug Safety (MFDS) drug registration process in South Korea. We dive into the relaxation of mandatory domestic clinical trials in favour of multinational Phase 3 data, the expansion of the conditional approval pathway for innovative medicines, and the increasing alignment of biosimilar frameworks with international standards. The discussion also covers practical submission strategies using the EZDRUG system and what sponsors should expect regarding review timelines and pharmacovigilance obligations in this evolving…
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