建立中药新药质量控制体系的实践与思考  

Establishing Quality Control System for New TCM Drugs: Practice and Considerations

作　　者：李培 马秀璟[1] LI Pei;MA Xiu-jing(Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2021年第9期16-23,共8页China Food & Drug Administration Magazine

摘　　要：为推动中药传承创新发展,加快具有临床价值的中药新药上市,促进产业高质量发展,本文结合如何构建符合中药特点的技术标准体系,对做好中药新药质量控制,落实"全过程质量控制""质量源于设计"及"新药研究的渐进性"等基本思路进行探讨,为完善符合中药特点的质量控制体系提出思考与建议,供同仁参考。In order to promote inheritance,innovation and development of traditional Chinese medicine(TCM),accelerate approval of new TCM drugs with clinical value,and advance healthy development of the industry,this article introduces the establishment of technical standard system in line with the characteristics of TCM,and discusses the basic principles for strengthening quality control of new TCM drugs,including"whole process quality control","Quality by Design"and the"progressive nature of new drug research".The authors hope to provide insights and suggestions for improving the quality control system in line with the characteristics of TCM.

关 键 词：中药新药 中药特点 全过程质量控制 质量源于设计 新药研究的渐进性 

分 类 号：R95[医药卫生—药学]