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NO&T Japan Legal Update
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.
条内将人
铃木谦辅、石本晃一(共著)、莫燕、德地屋圭治(中文版负责律师)
(2020年12月)
川合正伦
Roku(鹿) Haseru