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

Author: Yoshinobu Koyama

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Publisher: Nagashima Ohno & Tsunematsu

Journal / Book: NO&T Japan Legal Update No.12 (December, 2017)

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*Please note that this newsletter is for informational purposes only and does not constitute legal advice. In addition, it is based on information as of its date of publication and does not reflect information after such date. In particular, please also note that preliminary reports in this newsletter may differ from current interpretations and practice depending on the nature of the report.

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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