regulatory science

To stimulate clinical development, the Japanese government introduced “pricing premium for the promotion of new drug development and elimination/resolution of off-label use” in 2010. Using statistical analysis, we aimed to verify the acceleration of clinical development in therapeutic areas that are positive factors for receiving reward premiums. We defined “encouragement for clinical development” as the Pharmaceuticals and Medical Devices Agency (PMDA) review time in each therapeutic area compared with that in all therapeutic areas together. The dataset for this research was created from publicly available information on the PMDA website. New molecule entities (NMEs) between 2000 and 2016 in Japan were selected as the drugs of interest. Univariate regression analysis, Wilcoxon signed-rank test, and logistic regression analysis were conducted. The number of NMEs has been decreasing over time except for B (blood and blood-forming organs). The review time was significantly shorter for A (alimentary tract and metabolism), B, J (anti-infective for systemic use), and L (antineoplastic and immunomodulating agents) compared with that for all anatomical therapeutic chemical (ATC) codes together. The review time was significantly longer for C (cardiovascular system), and S (sensory organs). From logistic regression analysis, A, B, J, and L were identified as significant positive factors to shorten the review time. In conclusion, the present study has demonstrated that clinical development in Japan has been encouraged in therapeutic areas with unmet medical needs as the PMDA review time is shortened. This study assessing the review time per ATC code is consistent with our first report where the review time per office of new drug was investigated.