On June 17th, 2014, the Ministry of Health, Labour and Welfare (MHLW) announced the "Strategy of SAKIGAKE" to lead the world in the practical application of innovative medical products.
The "Strategy of SAKIGAKE" covers from basic research to clinical research/trials, approval reviews, safety measures, insurance coverage, improvement of infrastructure and the environment for corporate activities, and global expansion.
One of the major policies of the "Strategy of SAKIGAKE" is the "SAKIGAKE Designation System," which promoting R&D and early clinical research/trials in Japan aiming at early practical application for innovative medical products with prospective significant efficacy by conducting priority consultations, prior assessment, and priority reviews.
Together with MHLW, PMDA will work towards implementation of the strategy.
Please refer to the following web site for the "Strategy of SAKIGAKE" announced by MHLW.
http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/140729-01.html