www.mhlw.go.jp/stf/houdou/0000102009.html

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「先駆け審査指定制度」の対象品目を初めて指定しました｜厚生労働省

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https://www.mhlw.go.jp/stf/houdou/0000102009.html

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This page announces that Japan's Ministry of Health, Labour and Welfare has designated six pharmaceutical products for the first time under the "Breakthrough Therapy Designation System." The system was introduced to accelerate drug development and approval for innovative new medications treating serious diseases. It shortens the standard review period from 12 months to 6 months through priority consultation, enhanced pre-evaluation, and expedited review. The six designated drugs target various conditions including tuberous sclerosis complex, Duchenne muscular dystrophy, influenza, hereditary angioedema, acute myeloid leukemia, and gastric cancer.