The Sakigake designation was first announced as a pilot by the Ministry of Health, Labour and Welfare on 17 June 2014.
The designation system is part of a wider strategy, also named Sakigake, to promote R&D and improve access to new pharmaceuticals.
[2] The Pharmaceutical & Medical Device Act Amendments of 2019, which entered into force on 1 September 2020, made the Sakigake designation system a permanent fixture.
The Sakigake designation opens up the possibility for sponsors to seek pre-application consultations, which provide clients with a fixed-price multi-track review of their application.
[4] As of 31 December 2020[update], 24 drugs received Sakigake designation, but only 8 of these (33.33%) were approved.