中药上市后再评价技术规范制定的必要性及其形成方法研究  

Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance

作　　者：张雯[1] 谢雁鸣[1] 宇文亚[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2013年第18期2943-2948,共6页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030)

摘　　要：通过全面梳理WHO、美国及欧盟药物上市后再评价相关法律法规、技术规范和指南,对比我国中药上市后再评价的法规制度现状,发现由于中药上市后再评价起步较晚,尚未制定出相应的技术规范和指南,使得医院、企业和科研机构在开展相关工作时无据可依,比较混乱。因此制定中药上市后再评价技术规范迫在眉睫。该文在《国家标准制定程序》以及《中医药标准制定管理办法(试行)》等技术文件的指导下,结合我国中药上市后再评价的具体特点,探索出适合我国中药上市后再评价技术规范的制定方法,并就其制定程序和方法做以介绍,旨在为今后相关技术规范的制定提供方法学的参考和借鉴,以促进我国中医药事业的发展。Combining the world health organization＇s （WHO）, the United States and the European union＇s relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine（TCM） in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines arc yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, ＂procedures to formulate national standards＂ and ＂testing methods of management in formulating traditional Chinese medicine standards＂ and has combined these to produce a version of post-marketing surveillance particu- lar to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

关 键 词：上市后再评价 中药 技术规范 方法 

分 类 号：F326.12[经济管理—产业经济] R288[医药卫生—中药学]