FDA的发展历史和监管历程

拥有百年历程的美国食品及药品管理局（FoodandDrugAdministration,FDA）是全球食品药品监管最具权威的机构,其发展和监管历史中最重要的部分是不断面临执法挑战,但FDA始终不断完善立法,积极探索适合本国国情的监管模式。本文介绍了美国食品及药品管理局FDA的机构发展历史、监管历程、现行组织框架,以及美国药品评价与研究中心（CenterforDrugEvaluationandResearch,CDER）和生物制品评价与研究中心（CenterforBiologicsEvaluationandResearch,CBER）的历史沿革、组织框架、人员结构等。重点讨论了FDA所经历的挫折教训和成功经验,并通过梳理历史事件,解读了FDA的法规体系。FDA的发展历史和监管历程对中国药品监管事业诠释"维护和促进公众健康"的使命具有重要的参考意义。

Developmental and Regulatory History of Food and DrugAdministration

TThe USA Food and Drug Administration (FDA) has an over 100-year history and is the most authority drug administration. During its past records, the most important thing for FDA is facing law enforcement challenges. However,FDA insists on improving legislation and finding the perfect mode of regulation. This paper introduced the history evolution, regulatory course, present office structure of FDA, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER). The frustration and experience for FDA is well discussed. The legislation system is interpreted through historical events. To learn the developmental and regulatory history of USA food and drug administration is important to our drug administration for practicing the mission of protecting and promoting public health.