我国药品监管体系框架及构成要素研究

Study on the Framework and Constituent Elements of Chinese Drug Supervision and Administration System

目的:构建我国药品监管体系的理论框架,并探讨其构成要素。方法:采用文献法、比较法和归纳法进行分析。结果:我国现行的药品监管体系主要包含药品行政垂直监管组织体系、药品监管决策支撑体系、药品监管人力资源管理体系、药品监管法律保障体系、药品监管信用保障体系五大要素。结论:除药品监管信用保障体系处于起步和探索阶段外,其它体系目前已基本建立并处于逐步完善过程之中。建立健全药品监管信用保障体系是药品监管部门的当务之急。

OBJECTIVE： To construct the theoretical framework of Chinese drug supervision and administration system, and to analyze its constituent elements. METHODS：Methods of literature review, comparison, and induction were adopted. RESULTS： There are five key elements in Chinese drug supervision and administration system： vertical system of the drug administrative authorities, decision supporting system of drug supervision and administration, human resource management system,legal system and credit system of drug supervision and administration .CONCLUSIONS：Except the credit system which is at the fledgling stage and still to be probed, other systems have already been established and are being perfected gradually.To establish and improve the credit system should be the priority for the drug supervision and administration authorities.