摘要
本文通过回顾中药注册管理法规和中药药学研究技术指导原则的发展历程,介绍了中药药学研究技术指导原则评价体系,总结中药药学研究的基本要求和基本原则,以期对业界同仁有所帮助。
This article reviews the development history of regulations on traditional Chinese medicine(TCM)registration and CMC(chemistry,manufacturing,and controls)Guidances for TCM.The authors introduce the evaluation system for TCM CMC Guidances,and summarize the basic requirements and principles regarding CMC for TCM,hoping to provide support for the industry.
作者
赵巍
阳长明
周思源
胡流芳
杨平
ZHAO Wei;YANG Chang-ming;ZHOU Si-yuan;HU Liu-fang;YANG Ping(Center for Drug Evaluation,National Medical Products Administration)
出处
《中国食品药品监管》
2021年第9期56-63,共8页
China Food & Drug Administration Magazine
关键词
中药药学
指导原则
中药注册管理
CMC for traditional Chinese medicine
Guidance
TCM registration management
