(Japanese)

 The Ministry of Health, Labour and Welfare (MHLW) has formed the “Strategy of SAKIGAKE” by Ministry Project Team to lead the world in the practical application of innovative medical products (Press release (in Japanese) This PT has been launched to plan strategies as a package covering from basic research to the practical application with related divisions within the MHLW.

 The Strategy of SAKIGAKE consists of two measurements as follows and 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.

• SAKIGAKE Designation System: promoting R&D in Japan aiming at early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines.
• Scheme for Rapid Authorization of Unapproved Drugs: accelerating the practical application of unapproved/off-label use of drugs for serious and life-threatening diseases by expanding the scope of the Council on Unapproved Drugs/Off-label Use to include unapproved in Western countries if it satisfies certain conditions and by improving the environment for companies to undertake development of such drugs.

The MHLW will implement these policies during the budgetary request process in FY2015, but some of them which are ready will be executed in 2014 ahead of schedule.

＜Materials＞

• Strategy of SAKIGAKE (PDF:379KB)
• Summary of Strategy of SAKIGAKE (PDF:587KB)