Delays in psychiatric drug development in Japan
Delays in psychiatric drug development in Japan
复制标题
DOI：
10.1111/j.1365-2710.2011.01311.x
复制
发表时间：
2012-06-01
影响因子：
2
通讯作者：
Ikeda, M.
中科院分区：
文献类型：
--
作者：
Shimazawa, R.;Kusumi, I.;Ikeda, M.
已知和目标：日本与其他国家在精神科药物的批准和开发方面的滞后一直是精神病患者和精神科医生的主要问题。本研究的目的是分析导致日本推迟推出新的精神科药物的因素。研究方法：我们分析了来自日本、美国和英国的23种标准精神病药物的批准数据，并研究了可能导致其上市延迟的潜在因素。结果如下：在美国和英国批准的23种标准精神病药物中，只有13种在2000年9月至2011年7月期间引入日本。他们的开发策略均未采用ICH E5关于全球范围内同时开发药物的指导原则。13种药物中有12种（不包括托莫西汀）在美国和英国获得批准后在日本获得批准。这13种药物在日本的中位审查时间（从申请批准到获得批准）为23个月，远长于美国食品药品监督管理局和欧洲药品管理局的审查时间（分别为10.0和13.5个月）。1013个月的审查时间差异无法解释在美国或英国获得批准后在日本的总体延迟87个月和51个月。什么是新的和结论：尽管日本药品审批制度进行了几项重要改革，但在获得标准精神病药物方面，日本与美国和英国等西方国家之间仍存在很大差距。
What is known and Objective: The lag in the approval and development of psychiatric drugs between Japan and other countries has been a major issue both for patients with psychiatric diseases and for psychiatrists. The objective of this study was to analyse factors contributing to delays in launching new psychiatric drugs in Japan. Methods: We analysed data from Japan, the USA, and the UK for the approval of 23 standard psychiatric drugs and examined potential factors that might have contributed the delay of their launch. Results: Of the 23 standard psychiatric drugs, all of which were approved in the USA and the UK, only 13 were introduced in Japan between September 2000 and July 2011. None of their development strategies adopted the ICH E5 guideline on simultaneous development of drugs on a global scale. Twelve of the 13 drugs (not including atomoxetine) were approved in Japan after their approval in the USA and the UK. The median review time (from approval application to approval) of these 13 drugs in Japan was 23 months, which was considerably longer than those of the US Food and Drug Administration and European Medicines Agency (10.0 and 13.5 months, respectively). The 1013-month difference in review time cannot explain the overall 87- and 51-month delay in Japan after approval in the USA or UK. What is new and Conclusion: There remains a large gap between Japan and Western countries, such as the USA and the UK, with regard to access to standard psychiatric drugs, despite several important reforms in the Japanese drug approval system.