Abstract
Under considering pharmaceutical and medical device industries as a growth engine, the government of Japan has strengthened pharmaceutical and medical device research and development (R&D) with various measures including establishment of Japan Agency for Medical Research and Development (AMED) in April 2015. Also the government conquered ‘drug-lag’, redundancy of review term for new drug, and the fact contributes toward transparency and reliability of the R&D in Japan. Pharmaceutical manufacturers, thus, have changed their business behavior for concentration of their investment toward R&D, collaboration with academia, and globalization. These transformations give the government new opportunity for activating R&D. The past purpose of activation was mainly aiming for conquest of ‘drug-lag’, and the recent one is aiming for arousing innovation. The Sakigake review is one of the new approaches for breakthrough products. This article tries to introduce the scheme of Sakigake review and the background of R&D circumstance in Japan.
