美国食品和药物管理局质量量度管理的简介及启示

Brief introduction on United States Food and Drug Administration's quality metrics and its implication

美国食品和药物管理局《质量量度要求指南(草案)》的发布,预示着美国基于现场检查发现问题的监管模式即将发生转变。本文对质量量度的概念及发展、目标和主要内容进行简介,从质量量度及指南所体现的监管理念方面提出对完善我国药品监管的启示。

The draft of the Request for Quality Metrics Guidance for Industry was issued by the United States Food and Drug Administration（ FDA）, which indicates that the coming change about the on-site-inspection-based supervision mode in United States. This paper briefly introduced the concept, development,objectives and main contents of quality metrics, and put forward some implications for improving our country＇ s drug supervision from the regulatory philosophy embodied in quality metrics and the guidance.