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.
Kenji Tosaki, Nozomi Kato (Co-author)
(April 2025)
Kenji Utsumi, Kensuke Suzuki (Co-author)
Kenji Tosaki, Masato Kumeuchi, Soichiro Unami (Co-author)
(March 2025)
Yoshinobu Koyama, Masato Kumeuchi, Masanori Tosu (Co-author)
