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On the amendments of China′s Provisions for Drug Registration
Zhao, Naiqing2; Yao, Chen3; Chen, Jie1
关键词China Drug Registration Clinical Trial Import Drug Generic Drug
刊名DRUG INFORMATION JOURNAL
2008
42期:5页:467-475
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Health Care Sciences & Services ; Pharmacology & Pharmacy
研究领域[WOS]Health Care Sciences & Services ; Pharmacology & Pharmacy
英文摘要

China′s recently amended and released Provisions for Drug Registration differ from the previous ones in that they have greater emphasis on creating a high standard for drug safety by improving supervision of the registration process and upgrading drug evaluation and approval standards to encourage innovation. Specifically, the new regulation (1) redefines the concept of "new drugs"; (2) specifies the drug categories deserving special approval process; (3) simplifies the contents for preclinicol and clinical trial requirements; (4) introduces the term generic drugs; (5) imposes stricter requirements for drug reregistration, supplementary registration, and approval for manufacturing processes and drug package inserts; (6) articulates specific circumstances under which a drug registration application can be denied; (7) adjusts the timelines for the evaluation and approval process; and (8) details legal responsibilities for regulatory personnel and drug registration applicants. The article provides some insights on the amendments of the new Provisions for Drug Registration in China.

语种英语
WOS记录号WOS:000258991800007
引用统计
被引频次:2[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/51415
专题北京大学第一临床医学院
北京大学第一临床医学院_医学统计室
作者单位1.Merck Res Labs, Invest Res, N Wales, PA 19454 USA
2.Fudan Univ, Sch Publ Hlth, Dept Biostat, Shanghai 200433, Peoples R China
3.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
推荐引用方式
GB/T 7714
Zhao, Naiqing,Yao, Chen,Chen, Jie. On the amendments of China′s Provisions for Drug Registration[J]. DRUG INFORMATION JOURNAL,2008,42(5):467-475.
APA Zhao, Naiqing,Yao, Chen,&Chen, Jie.(2008).On the amendments of China′s Provisions for Drug Registration.DRUG INFORMATION JOURNAL,42(5),467-475.
MLA Zhao, Naiqing,et al."On the amendments of China′s Provisions for Drug Registration".DRUG INFORMATION JOURNAL 42.5(2008):467-475.
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