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  • MFDS to ease orphan drug designation eligibility criteria
  • by Lee, Tak-Sun | translator Hong, Ji Yeon | Nov 6, 2025 06:32am
Comparative data related to alternative medicine will be exempt
National briefing on top 50 food and drug safety tasks¡¦"will add security to safety"
 ¡ã Yu-Kyoung Oh, Minister of the MFDS, is speaking at the
As the criteria for Orphan Drug Designation are set to be significantly eased, this is expected to expand the introduction of rare disease treatments currently not approved in Korea.

The Ministry of Food and Drug Safety (MFDS) plans to revise the regulations by February of next year.

The MFDS announced this during the 'Top 50 Food and Drug Safety Tasks National Briefing Session' held on the 5th at the International Conference Hall on the first floor of the Seoul Foundation of Women and Family in Dongjak-gu, Seoul.

The relaxation of the Orphan Drug Designation requirements was introduced as the very first of the seven key projects.

Yu-Kyoung Oh, Minister of the MFDS, said, "We will ease the designation req
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