全程式中药安全性评价和监管  

The whole-process safety evaluation and supervision of traditional Chinese medicine

作　　者：韩玲[1] 孙祖越[2] 杨威 王海学[1] 宋海波 HAN Ling;SUN Zu-yue;YANG Wei;WANG Hai-xue;SONG Hai-bo(Center for Drug Evaluation,National Medical Products Administration,Beijing 100038,China;National Evaluation Center for the Toxicology of Fertility Regulating Drug,Shanghai Institute of Planned Parenthood Research,Shanghai 200032,China;Guangdong Provincial Key Laboratory of Drug Non-clinical Evaluation and Research(Guangdong Lewwin Pharmaceutical Research Institute Co.,Ltd),Guangzhou 510260,China;Center for Drug Reevaluation,National Medical Products Administration,Beijing 100038,China;Division of Life Science,Hong Kong University of Science and Technology,Hong Kong 999077,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100038 [2]上海市计划生育科学研究所,中国生育调节药物毒理检测中心,上海200032 [3]广东省药物非临床评价研究重点实验室(广东莱恩医药研究院有限公司),广东广州510990 [4]国家药品监督管理局药品评价中心,北京100038 [5]香港科技大学生命科学部,香港999077

出　　处：《中国药理学与毒理学杂志》2020年第11期801-810,共10页Chinese Journal of Pharmacology and Toxicology

基　　金：广东省药物非临床评价研究重点实验室(2018B-030323024)。

摘　　要：中药的安全性评价源于临床,承于非临床,最后又回到临床,故称“全程式的中药安全性评价”,即中药的安全性评价贯穿于从药物发现或临床人用经验到上市应用的全过程,也可以说中药毒性评价循证于“临床-非临床-临床-上市后再评价”,其警戒也应贯穿于药品全生命周期。所以,针对中药的特殊性,安全性风险管理应贯穿于中药材的种植和溯源、炮制和加工、生产工艺和全过程质控,也要体现在系统规范及有针对性的毒理学研究、规范和风险可控的临床试验以及上市后的再评价的全过程之中。这一过程应体现申请人或上市许可持有人的主体责任,不仅是需要研发机构、安全性评价机构本着为用药人群的安全负责的科学评价、提升安全管理意识和能力,同时也需要监管部门切实履行监管职责。Safety evaluation of traditional Chinese medicine(TCM)originates from clinical practice,is inherited from non-clinical studies,and finally returns to clinical application.This process is called the whole-process safety evaluation of TCM.The safety evaluation of TCM covers the whole process from drug discovery or clinical human use to market application.This process is evidence-based and spans from clinical,non-clinical,clinical to post-marketing re-evaluation,and pharmacovigilance should run through the life cycle of drugs.Given the distinct character of TCM,safety risk management should run through the planting,tracing,processing,production and quality control of TCM,as well as through systematic and standardized toxicological research,standardized and risk-controllable clinical trials and post-marketing re-evaluation.This process should reflect the main responsibility of the applicants or the holders of the marketing license.Research and development institutes and safety evaluation institutes need to enhance the safety management awareness and capabilities of the medication population.Regulators are also required to fulfill their responsibilities.

关 键 词：中药 安全性评价 药物警戒 

分 类 号：R951[医药卫生—药学] R288