Shoyo Shibata1, Koji Chiba2, and Takeshi Suzuki1*
1.Division of Basic Biological Sciences, Faculty of Pharmacy, Keio University, Tokyo, Japan
2.Laboratory of Clinical Pharmacology, Faculty of Pharmacy, Yokohama University of Pharmacy, Kanagawa, Japan
In 2010, a premium rewards system for the promotion of innovative drug discovery was introduced in Japan, which aimed to further the development of innovative new medicines to meet the high level of unmet medical needs present in Japan. Previous research indicated that anti-cancer agents, immune-suppressants, and neuroscience drugs comprised the drug categories that significantly contributed to receive this reward premium. In this study, the number of new molecule entities (NMEs) approved in Japan between 2000 and 2015, along with their review times by the Pharmaceuticals and Medical Devices Agency (PMDA), were investigated to elucidate the actual clinical development status in Japan under this reward system. The dataset used in this study was created from publicly-available information on the PMDA website. For analysis, univariate regression analysis and Wilcoxon signed-rank test were used. Significant upward trends were observed in the total number of NMEs approved by the Offices of New Drug III, IV, V, and the Vaccines and Blood Products Office. No significant differences in the number of NMEs between 2000 and 2015 for each New Drug Office were observed. The median review time was 14 months; the maximum review time was 21 months (Office of New Drug III) and the minimum review time was 12 months (Offices of New Drug IV and V), excluding the Office of Vaccines and Blood Products (11 months). The review period was significantly shortened over time in the Offices of New Drug I and II. Our study suggests that the development of new drugs in therapeutic areas with high unmet medical needs has been adequately promoted in Japan, along with reasonably shortened PMDA review times.
Keywords: Japanese pharmaceutical companies, clinical development, drug development, drug pricing, PMDA