The changing landscape of clinical trial and approval processes in China

被引:0
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作者
Qing Zhou
Xiao-Yuan Chen
Zhi-Min Yang
Yi-Long Wu
机构
[1] Qing Zhou and Yi-Long Wu are at the Guangdong Lung Cancer Institute,
[2] Guangdong General Hospital and Guangdong Academy of Medical Sciences,undefined
[3] 106 Zhongshan Er Road,undefined
[4] Guangzhou 510080,undefined
[5] China.,undefined
[6] Xiao-Yuan Chen and Zhi-Min Yang are at the Center for Drug Evaluation (CDE),undefined
[7] China Food and Drug Administration (CFDA),undefined
[8] 26 Xuanwumen Xidajie,undefined
[9] Beijing 100053,undefined
[10] China.,undefined
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摘要
The expansion of research and development of anticancer drugs in China has resulted in considerable delays in the approval of both clinical trials of novel agents, and the marketing approval of these agents once tested. In this Perspective, the authors describe the measures taken by the Chinese FDA to address these challenges in a rapidly developing research environment.
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页码:577 / 583
页数:6
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