Sakigake (drug designation)
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. The Pharmaceutical & Medical Device Act Amendments of 2019, which entered into force on 1 September 2020, made the Sakigake designation system a permanent fixture. While application for the Sakigake designation was only open for a short period every year, the permanent Sakigake regime is open year-round. 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. , 24 drugs received Sakigake designation, but only 8 of these (33.33%) were approved.
History
Sakigake (さきがけ, lit.