「先駆け審査指定制度」の対象品目を指定しました｜厚生労働省
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「先駆け審査指定制度」の対象品目を指定しました｜厚生労働省
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This page announces the Ministry of Health, Labour and Welfare's designation of five pharmaceutical products under the "Breakthrough Therapy Designation System" on April 21, 2017. Out of 47 applications, five new drugs were approved. The system aims to accelerate development and approval of innovative medicines for serious conditions by reducing review periods from the standard 12 months to 6 months. Designated products include Olipudase alfa, aducanumab, DS-5141b, SPM-011, and nivolumab from companies such as Sanofi, Biogen Japan, Daiichi Sankyo, Stella Pharma, and Ono Pharmaceutical.
