The “SAKIGAKE” Designation System: Accelerating the Approval Process of Pharmaceuticals in Japan

I. Introduction
The Ministry of Health, Labour and Welfare of Japan (the ‘MHLW’) introduced the “SAKIGAKE” designation system in 2015 (in Japanese, ‘sakigake shinsa shitei seido’) (the ‘SAKIGAKE Designation System’), aiming to accelerate the time to market for innovative pharmaceuticals by providing a series of benefits in both the pre‐application and review stages of the approval process. On December 15, 2017, the MHLW approved the first pharmaceutical selected under the SAKIGAKE Designation System.

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