ended4월 14일· 1 sources
식약처, 제2 자큐보 지원…GIFT로 신약 상용화 앞당긴다 [현장+]
Why it matters
The GIFT program shifts regulatory engagement to the earliest stages of R&D, significantly reducing the 'valley of death' in drug development through pre-clinical and clinical design optimization. As its criteria align with global standards like FDA's BTD and EMA's PRIME, it provides South Korean biotech companies with a strategic validation signal for faster international market entry.
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GIFTMFDSdrug developmentINDBreakthrough Therapy Designationclinical trial