Closing the Drug Lag for New Drug Submission and Review in Japan: An Industry Perspective
Closing the Drug Lag for New Drug Submission and Review in Japan: An Industry Perspective
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DOI：
10.1002/cpt.192
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发表时间：
2015-11-01
影响因子：
6.7
通讯作者：
Poirier, A. F.
中科院分区：
文献类型：
--
作者：
Poirier, A. F.
以前的出版物都集中在日本的药物滞后和政府为解决这种情况而采取的举措。(1)日本是第三大药品市场，但多年来一直经历着严重的药物滞后。本文回顾了将日本纳入全球药物开发计划的行业适应新的监管模式所取得的进展。
Previous publications have focused on drug lag in Japan and the government's initiatives to address the situation.(1) Japan is the third largest pharmaceutical market, and yet has experienced significant drug lag for many years. This article reviews the progress resulting from industry adaptation of new regulatory paradigms that include Japan in global drug development programs.