中成药上市后再评价临床试验政策法规及操作规范探讨  

Discussion of the laws and regulations and operation specifications on postmarketing reevaluation of Chinese patent drugs

作　　者：李博[1] 高蕊[1] 李睿[1] 陆芳[1] 訾明杰[1] 唐旭东[1] 

机构地区：[1]中国中医科学院西苑医院药物临床试验机构,北京100091

出　　处：《中国新药杂志》2014年第6期650-653,664,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2012ZX09303-010-002);国家自然科学基金青年项目(81303151)

摘　　要：目的:探讨国外药品上市后再评价的法律法规及操作规范,为中成药上市后再评价的法律法规及操作规范目前正在制订,提供参考。方法:纵览当前国际国内的上市后再评价,尤其是中药的上市后再评价的法律法规及规范标准,进行总结,归类和比较。结果:WHO、美国、欧盟,亚太地区等的上市后再评价的法律法规及操作标准,并得到中国当前的上市后再评价的法律法规及操作标准进行剖析。结论:当前中药上市后临床评价的法律法规主要是:《药品再评价管理办法(草案)》,临床操作标准是《药品上市后临床试验指导原则(草案)》。思考与展望:当前国内的法律法规还不健全,很多技术规范还没有进行修订和征求意见阶段尚未正式发布,尚无专门的中药上市后评价的相关法律和操作规范。建议专门起草当前的中成药上市后再评价的法律及技术规范研究并尽快发布。Objective： To study the laws and regulations and operation specifications on the postmarketing reevaluation of Chinese patent drugs. Methods： All of the international and local laws and regulations and opera- tion specifications were reviewed. Results： The recent laws and regulations and operation specifications for post- marketing clinical trial and study of Chinese patent drugs were found and analyzed. Conclusion： There are very few laws and regulations and operation specifications for the postmarketing reevaluation of Chinese patent drugs. It＇s sug- getsted that relevant laws and regulations and operation specification be developed and issued as soon as possible.

关 键 词：中成药 上市后评价 临床试验 循证 政策法规 操作规范 

分 类 号：R95[医药卫生—药学]