MHLW state that The SAKIGAKE designation system regulated from 2021. The application timing is expanded twice a year, April and October. The Innovative products have more chance to accelerate product development in Japan.
The criteria for the SAKIGAKE are 1) Innovative products, 2) Life threatening or no radical treatment, 3) Prominent efficacy, 4) First NDA in the world.
MHLW set clearly that the First NDA in the world states Japan NDA should completed within 30 days after Worldwide first NDA.
The SAKIGAKE system should be leveraged with innovative products.
What is the SAKIGAKE designation system (June 17, 2014)