Laboratory of Pharmaceutical Regulatory Sciences, Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan.
Clin Pharmacol Ther. 2010 Feb;87(2):212-8. doi: 10.1038/clpt.2009.215. Epub 2009 Nov 25.
The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.
日本在新药获取方面与美国（美国）和欧盟（欧盟）之间的差距正在成为日本的一个主要问题。我们分析了日本、美国和欧盟新药申请（NDA）和生物许可证申请提交之间的时间滞后，以确定延迟获取的原因。许可产品和非日本公司的申请提交时间滞后（“提交滞后”）更长。与临床试验成本和潜在销售数量相关的因素与提交滞后无关。桥接策略（根据国际协调会议指导原则 E5 在临床数据包中推断使用外国临床数据）似乎可以减少提交滞后，但当具体调查因果关系时，两者之间的关联减弱。这些结果表明，跨国公司在决定将其药品引入日本时，更有可能强调成功实现其目标的开发策略选择，而不是直接成本和预期销售额。我们的研究结果表明，有助于制药公司决定投资和策略的临床开发指南也是缩小新药获取差距的关键。
