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目的:介绍FDA近期发布的突发事件应急管理方面的文件《应急运行计划》,为完善我国的药品应急预案提供建议。方法:通过查阅FDA网站,大量应急管理的文献、法规,危机管理的相关理论书籍,运用比较研究的方法分析了中美两国的药品应急预案。结果:我国药品应急预案已经进入了法治化进程,其内容的科学性、完整性、可操作性方面与FDA的《应急运行计划》存在较大差距。结论:首先是应急预防、预警实现常规化;其次是设立专门的应急管理机构;再次是实现预案管理等。
OBJECTIVE: To introduce the “emergency operation plan” document recently released by the FDA on emergency management of emergencies and to provide suggestions on how to improve our country’s drug emergency plan. Methods: Through the FDA website, a large number of emergency management literature, laws and regulations, crisis management theory books, the use of comparative study of the analysis of the drug emergency plan in China and the United States. Results: The medical emergency plan of our country has entered the process of legalization. There is a big gap between its scientific, completeness and operability with the FDA’s “emergency operation plan”. Conclusion: The first is emergency prevention, warning to achieve the normalization; followed by the establishment of specialized emergency management agencies; and once again to achieve the plan management.