Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
Clin Pharmacol Ther. 2010 Oct;88(4):487-91. doi: 10.1038/clpt.2010.108. Epub 2010 Aug 25.
The length of clinical development and review procedures related to new drugs approved in Japan in 2000-2009 were analyzed. The length of time taken for clinical development varied depending on diversification of strategies, and the review times showed a decline during this period. Regression analyses suggested that clinical development times were significantly shorter for non-new molecular entities (non-NMEs), priority reviews, conditional approvals, and drugs utilizing foreign clinical data. The review times were shorter for new drug applications (NDAs) submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) and for priority reviews. The effects of pre-NDA consultations were mixed; the review time was shorter, but the clinical development period was prolonged.
分析了 2000-2009 年在日本批准的新药的临床开发和审查程序的长度。临床开发所需的时间因策略的多样化而异，在此期间，审查时间呈下降趋势。回归分析表明，对于非新分子实体（非-NME）、优先审查、有条件批准和利用国外临床数据的药物，临床开发时间更短。新药申请（NDA）提交给药品和医疗器械管理局（PMDA）和优先审查的审查时间更短。预 NDA 咨询的效果参差不齐；审查时间缩短了，但临床开发周期延长了。
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