SARS流行期间中美药品监管之比较

Comparative Study on the Drug Administration between U.S. and China during SARS Breakout

SARS作为一种新发传染病 ,它的爆发和流行给各国政府和民众带来了极大的压力和恐慌。为了解SARS流行期间预防性用药的使用情况、随之带来的危害以及影响因素 ,我们组织了大规模的流行病学调查 ,还收集了有关国家或地区采取的应急政策。本文对中、美两国药品行政部门在SARS流行期间的新药申请审批、医药储备管理、药品检验、市场规范等多方面进行了比较 ,以期为今后发生类似突发事件时进行政府决策提供依据。

SARS is a kind of new infectious disease. Its breakout and prevalence have brought an infinite pressure and scare to the government and the public of many countries. A large-scale epidemiological study has organized in order to investigate the using of preventive medicines and some literatures of policy concerning about the emergency control are collected. A review are made on the drug administration between U.S. and China, such as the NDA, the management of drug store, the quality control and market regulation, in this paper. It will give some basis to the government's decision when occur similar incident in the future.