摘要
为制定并完善符合中药特点的中药质量控制体系,国家药品监督管理局药品审评中心于2020年12月17日发布了《中药生物效应检测研究技术指导原则(试行)》,本文结合起草背景,对指导原则进行解读,阐述本指导原则制定的目的、意义和内容。
In order to establish a quality control system for traditional Chinese medicine(TCM)in line with its characteristics,the Center for Drug Evaluation of NMPA issued the Guidance on Biological Assay for Traditional Chinese Medicine(Interim)on Dec.17,2020.This article interprets the guidance by introducing its background,purpose,significance and contents.
作者
李慧
朱家谷
杨平
陈浩
吴静义
刘思燚
王伽伯
肖小河
马秀璟
LI Hui;ZHU Jia-gu;YANG Ping;CHEN Hao;WU Jing-yi;LIU Si-yi;WANG Jia-bo;XIAO Xiao-he;MA Xiu-jing(Center for Drug Evaluation,National Medical Products Administration;School of Traditional Chinese Medicine,Capital Medical University;China Military Institute of Chinese Medicine,Fifth Medical Center of Chinese PLA General Hospital)
出处
《中国食品药品监管》
2021年第9期88-93,共6页
China Food & Drug Administration Magazine
关键词
中药
生物效应
生物检测
指导原则
质量控制
traditional Chinese medicine
potency
biological assay
guidance
quality control
