摘要
国家食品药品监督管理总局于2018年发布《古代经典名方中药复方制剂简化注册审批管理规定》,明确经典名方制剂申请上市,可仅提供药学及非临床安全性研究资料,免报药效学研究及临床试验资料。该规定出台后引起热烈讨论,就经典名方制剂免药效及临床研究的合理性进行探讨,为明确相关政策内涵、推动经典名方研发和审批上市提供参考。
In 2018,the State Food and Drug Administration issued the administrative provisions on simplified registration and approval of ancient classical prescription,which made it clear that the application for listing of classical prescription could only provide pharmaceutical and non-clinical safety research data.The pharmacodynamic research and clinical trial data were not required to be provided.The regulation caused a heated discussion after its promulgation.In this paper,we briefly discussed the rationality of the drug efficacy and clinical research free of classical prescription,so as to provide a reference for clarifying the connotation of relevant policies,promoting the R&D and approval of classic famous prescription.
作者
蒋雨琦
房雨彤
李秋桐
何瑞欣
王琪
刘陶世
陈仁寿
程建明
JIANG Yu-qi;FANG Yu-tong;LI Qiu-tong;HE Rui-xin;WANG Qi;LIU Tao-shi;CHEN Ren-shou;CHENG Jian-ming(The First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, 210023, China;School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing, 210023, China;Institute of Traditional Chinese Medicine Literature, Nanjing University of Chinese Medicine, Nanjing, 210023, China)
出处
《南京中医药大学学报》
CAS
CSCD
北大核心
2020年第5期710-714,共5页
Journal of Nanjing University of Traditional Chinese Medicine
基金
江苏省自然科学基金(BK20181424)
南京中医药大学横向合作项目(2018053)。
关键词
经典名方
新药审批
临床试验
classical prescription
new drug approval
clinical trial
