关于中药儿童用药临床审评相关问题的思考  

Consideration on the clinical review in pediatric drug development of TCM

作　　者：杨娜 褚新颖 刘炳林[1] YANG Na;CHU Xinying;LIU Binglin(Center for Drug Evaluation of NMPA,Beijing 100038)

机构地区：[1]国家药品监督管理局药品审评中心,北京100038

出　　处：《中国医药工业杂志》2022年第11期1648-1653,共6页Chinese Journal of Pharmaceuticals

摘　　要：“中医药理论、人用经验和临床试验相结合”三结合审评证据体系的提出非常利好中药儿童用药的研发。文章立足于中药儿童用药审评工作中遇到的问题,从临床审评角度对儿科中药复方制剂的研发策略提出相关意见和建议,以供相关人员参考。The proposal of“the evidence system for TCM registration evaluation combining TCM theory,experiences in human use and clinical trials”is conducive to the research and development of Traditional Chinese medicine for children.Regarding to the situations encountered in the medical review,this article puts forward some suggestions and considerations from the perspective of clinical review for the reference of development of pediatric drug of TCM.

关 键 词：儿童用药 中药 “三结合”审评证据体系 人用经验 真实世界研究 

分 类 号：R95[医药卫生—药学]