What Factors Lead to Prolonged Regulatory Review Times for New Drugs in Japan?

Shigetomo Yoneda¹, Ryuta Asada^1,2,3*, Shinobu Shimizu⁴, Shunsuke Ono⁵ and Takuhiro Yamaguchi¹

¹Department of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan, E-mail: rasada@gifu-u.ac.jp

²Innovative and Clinical Research Promotion Center, Gifu University Hospital, Gifu, Japan, E-mail: rasada@gifu-u.ac.jp

³Clinical Research Center, National Hospital Organization Nagoya Medical Center, Japan, E-mail: rasada@gifu-u.ac.jp

⁴Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan, E-mail: rasada@gifu-u.ac.jp

⁵Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan, E-mail: rasada@gifu-u.ac.jp

^*Corresponding Author: Ryuta Asada, 1-1 Yanagido, Gifu City, 501-1194, Japan, Tel: 81-58-230-6650, Fax: 81-58-230-6651 Email: