美国CDC对传染性物质的进口监管制度概述

Overview of the CDC's Import Supervision System for Infectious Substances in United States

近年来,我国生物医药产业的飞速发展以及出入境特殊物品的增加,在给人民健康带来益处的同时,对我国的生物安全监管体系带来一定挑战。本文主要介绍了美国疾病控制与预防中心(CDC)对入境传染性物质的监管制度,主要包括联邦选择药剂程序和进口许可证程序。本研究对中美入境传染性物质的监管制度进行了比较研究,并探讨了美国入境传染性物质的监管制度对我国的启示。

With the development of Chinese biomedical industry and the increase of special items for entry and exit,it has brought challenges to Chinese bio-safety regulatory system in recent years.It introduces CDC's regulatory system for entry infectious substances in the United States,including Federal Select Agent Program and Import Permit Program.It conducted a comparative study on the regulatory systems of entry infectious substances in China and the United States,and explored the implications for China about the regulatory system.