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Delays in psychiatric drug development in Japan
R Shimazawa1, I Kusumi, M Ikeda
1Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Journal of Clinical Pharmacy and Therapeutics
|October 25, 2011
Summary
Psychiatric drug approvals in Japan significantly lag behind the USA and UK. This study analyzed factors contributing to these delays, finding review times insufficient to explain the overall gap in drug accessibility.
Area of Science:
- Pharmacology
- Drug Development
- Regulatory Science
Background:
- Significant delays exist in the approval and launch of psychiatric drugs in Japan compared to Western countries.
- This lag impacts patient access to essential treatments and poses challenges for psychiatrists.
Purpose of the Study:
- To investigate the factors contributing to the delayed introduction of new psychiatric drugs in Japan.
- To compare drug approval timelines and identify reasons for the disparity between Japan, the USA, and the UK.
Main Methods:
- Analysis of approval data for 23 standard psychiatric drugs in Japan, the USA, and the UK.
- Examination of potential contributing factors to launch delays in Japan, including adherence to International Council for Harmonisation (ICH) E5 guidelines.
Main Results:
- Only 13 of 23 psychiatric drugs were approved in Japan between 2000-2011, compared to full approval in the USA and UK.
- Japan's median drug review time was 23 months, significantly longer than in the USA (10 months) and UK (13.5 months).
- The extended review time does not fully account for the substantial overall delay (87 months post-USA, 51 months post-UK) in drug launches.
Conclusions:
- A considerable gap persists in patient access to standard psychiatric drugs between Japan and Western nations.
- Despite reforms, the Japanese drug approval system contributes to significant delays in making new treatments available.
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