SAKIGAKE Designation System in Japan (similar to Fast Track/Breakthrough Therapy in the US)

As described in the article “先駆け審査指定制度|AnswersNews Plus (” released by AnswersNews on 15/03/2019, the SAKIGAKE designation system is a program that grants preferential treatment to innovative products such as pharmaceuticals, medical devices, regenerative medicine products, and in vitro diagnostic drugs that are applied for approval in Japan for the first time in the world. This system shortens the standard 12-month approval period to 6 months for designated products. To be designated as a target product, it is necessary to demonstrate the ground-breaking nature of the product, the severity of the targeted disease, extremely high efficacy, and an intention to develop and apply early in Japan. The SAKIGAKE designation system provides preferential measures such as advancing the approval review process, prioritizing review, consultation on development progress management, and extending re-examination periods. In addition, a “SAKIGAKE designation system addition” is added to the drug price of target products as a premium, which serves as an incentive for drug development.