药品技术审评时限纳入法规的合理性讨论  

Discussion on Rationality of Drug Review Time Limit to Be Stipulated in the Regulation

作　　者：唐健元[1] 姜春菲[1,2] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038 [2]沈阳药科大学工商管理学院

出　　处：《中国药事》2014年第7期693-699,共7页Chinese Pharmaceutical Affairs

基　　金："重大新药创制"科技重大专项--"大品种药物Ⅳ期临床试验研究技术平台(创新药物研究开发技术平台建设)"(编号2011ZX09304)

摘　　要：目的探讨将药品技术审评时限写入法规中的合理性问题。方法通过分析人用药品注册技术要求国际协调会(ICH)成员国美国、日本及欧盟在法律中对药品技术审评时限的规定,并对美国、日本药品实际审评时限作简要统计。结合我国药品审评现状,进一步分析我国将药品技术审评时限写入法规中是否合理。结果与结论药品技术审评是一项复杂的技术工作,其考虑因素的复杂性远非法定时限的简单切割。所以,将药品技术审评时限写入《药品注册管理办法》中有欠妥之处。Objective To discuss whether it is reasonable that the regulation limits the drug review time in China. Methods Through analysis of the drug review time limit regulated by laws in FDA, PMDA and EMA, and statistics of the actual drug review time stipulated by the three agencies, in combination with the current situation of drug review in our country, a concrete discussion and analysis was made on whether it was reasonable to include the drug review time limit in laws in China. Results and Conclusion The drug evaluation is a complicated and technical work which would be affected by many factors, the complexity is far beyond simple definition of legal time limit. Therefore, it is not proper to include drug review time limit in the regulation of drug application.

关 键 词：药品 技术审评 审评时限 

分 类 号：R951[医药卫生—药学]