SAKIGAKE aims at shortening premarket review period for innovative new medical products that satisfy certain criteria, such as severity of intended indication, by designating such products during the early stages of development, and providing prioritized consultation services and premarket pharmaceutical affairs review.
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Sakigake Designation System
Published by IRDiRC
Regulatory AffairsOrphan DrugEarly Access SupportJapanMHLW or PMDA RegulatorySakigake