摘要
中药新药质量标准研究是中药新药研究的重要部分,完善的质量标准是保证中药安全有效和质量可控的基础。随着中药制剂的不断发展,新技术、新设备、新方法越来越多的应用于中药研究、生产领域,中药制剂质量控制要求和质量标准研究也在不断完善和发展,因此建立与时俱进的、完善的中药新药质量标准控制体系具有十分重要的意义。2020年10月由国家药品监督管理局药品审评中心发布的《中药新药质量标准研究技术指导原则(试行)》基于中药新药研究的全生命周期管理,具有阶段性的特点,遵循中医药发展规律,体现中药新药质量标准的研究、制定应与安全性、有效性相关联的宗旨,提出中药新药质量标准研究的基本原则和要求。为更好地理解本指导原则的内涵和意义,本文通过回顾中药质量标准研究发展历程及梳理其存在的主要问题,对《中药新药质量标准研究技术指导原则(试行)》的起草背景和主要内容进行介绍和分析,阐述质量标准研究应重点关注的方向,供同行参考。
An important part of the research on new drugs derived from traditional Chinese medicine(TCM)is research on the specifications for new TCM drugs,which are the basis for ensuring the safety,effectiveness and quality of TCM drugs.With the continuous development of TCM,more and more new technologies,new equipment and new methods are applied in the field of TCM research and production.At the same time,there has been improvement on the requirements for quality control and specifications for TCM products.Therefore,it is of great significance to establish an up-to-date and sound quality control system for new TCM drugs.The Guidance on Specifications for New TCM Drugs(Interim)released in October 2020 is based on lifecycle management of new TCM drug research and its characteristics of phased development.The Guidance follows the course of TCM development,reflects the purpose that research and setting of specifications for new TCM drugs should be relevant to drug safety and effectiveness,and puts forward the basic principles of and requirements for specifications for new TCM drugs.For a better understanding of the meaning and significance of the guidance,this paper reviews the development history of TCM specifications and the main problems,then introduces and analyses the drafting background and main content of the Guidance,with emphasis on important research subjects,providing support for industry.
作者
陈霞
关宏峰
赵巍
刘思燚
赵晓霞
CHEN Xia;GUAN Hong-feng;ZHAO Wei;LIU Si-yi;ZHAO Xiao-xia(Center for Drug Evaluation,National Medical Products Administration)
出处
《中国食品药品监管》
2021年第9期70-77,共8页
China Food & Drug Administration Magazine
关键词
中药
质量标准
指导原则
traditional Chinese medicine
specifications
guidance
