Rinsho Shinkeigaku (Clinical Neurology)

Original Article

Delays in clinical development of neurological drugs in Japan

Masayuki Ikeda, M.D.1)

1)Department Medical Informatics, Kagawa University Hospital

The delays in the approval and development of neurological drugs between Japan and other countries have been a major issue for patients with neurological diseases. The objective of this study was to analyze factors contributing to the delay in the launching of neurological drugs in Japan. We analyzed data from Japan and the US for the approval of 42 neurological drugs, all of which were approved earlier in the US than in Japan, and examined the potential factors that may cause the delay of their launch. Introductions of the 42 drugs in Japan occurred at a median of 87 months after introductions in the US. The mean review time of new drug applications for the 20 drugs introduced in Japan in January 2011 or later (15 months) was significantly shorter than that for the other 22 drugs introduced in Japan in December 2010 or earlier (24 months). The lag in the Japan's review time behind the US could not explain the approval delays. In the 31 of the 42 drugs, the application data package included overseas data. The mean review time of these 31 drugs (17 months) was significantly shorter than that of the other 11 drugs without overseas data (26 months). The mean approval lag behind the US of the 31 drugs (78 months) was also significantly shorter than that of the other 11 drugs (134 months). These results show that several important reforms in the Japanese drug development and approval system (e.g., inclusion of global clinical trial data) have reduced the delays in the clinical development of neurological drugs.
Full Text of this Article in Japanese PDF (353K)

(CLINICA NEUROL, 57: 274|279, 2017)
key words: clinical trials, drug approval, Food and Drug Administration, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, nervous system diseases

(Received: 6-Dec-16)