对药品质量定义的再探讨

明确药品质量的定义与内涵是进行药品质量相关研究的基础,但是目前我国尚没有形成药品质量的定义。本文从我国药品质量理念的变迁出发,阐述不同主体对药品质量定义的不同理解,发现存在的问题,再根据国内外对"质量"定义的研究,世界卫生组织药物政策中药品可及性问题,结合我国中药广泛存在的特殊现状,从合规性、符合要求、可及性和中药质量四个方面规范我国药品质量的定义。

Further discussion on the definition of drug quality

Clearing definition of drug quality is the basis for drug quality study,but there is not a definition of drug quality in China now.This paper analysed the changes in concepts of drug quality and the different understandings of different subjects on the definition of drug quality.The result showed that based on the study of the definition of quality at home and abroad,availability of drugs in WHO drug policy,and the special condition that traditional Chinese medicine was widespread,four aspects as compliance,meeting requirements,accessibility and the quality of traditional Chinese medicine should be emphasized to standardize the definition of drug quality in China.