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

著者等: 小山嘉信

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出版社: 长岛・大野・常松律师事务所

书籍名或刊登 杂志: NO&T Japan Legal Update 第12号（2017年12月）

语言: 英文

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请注意，本简报的目的是提供信息，并非提供法律建议。另外，本简报仅包括根据发行日(制作日)时点的信息，不包括该时点之后的信息。特别是速报可能会与现状的解释或惯例不同，敬请留意。

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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