中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2015年
1期
83-88
,共6页
美国食品药品监督管理局%应急医药产品%职能设计%紧急预案
美國食品藥品鑑督管理跼%應急醫藥產品%職能設計%緊急預案
미국식품약품감독관리국%응급의약산품%직능설계%긴급예안
FDA%medical countermeasures%functions design%emergency reserve plan
目的：对美国流行病和灾害性应急准备系列法案中美国食品药品监督管理局(FDA)职能定位进行分析，为我国政府部门的应急职能设计提供参考。方法：采取法案内容分析法，了解FDA在应急医药产品准备中的职能定位。结果：FDA在医药产品应急准备的根本职能是促进突发事件中应急医药产品的开发和使用的可获得性，包括发布医药产品的应急指导和安全警示信息，负责授权医药产品紧急使用权、延长医药产品保存期限及预置职能。结论：应重视国家级应急准备工作，完善应急准备的配套法律体系，准确定位“应急医药产品的应急预案”，加强应急医药产品的应急信息化管理，建设应急医药产品的快速调剂和使用机制。
目的：對美國流行病和災害性應急準備繫列法案中美國食品藥品鑑督管理跼(FDA)職能定位進行分析，為我國政府部門的應急職能設計提供參攷。方法：採取法案內容分析法，瞭解FDA在應急醫藥產品準備中的職能定位。結果：FDA在醫藥產品應急準備的根本職能是促進突髮事件中應急醫藥產品的開髮和使用的可穫得性，包括髮佈醫藥產品的應急指導和安全警示信息，負責授權醫藥產品緊急使用權、延長醫藥產品保存期限及預置職能。結論：應重視國傢級應急準備工作，完善應急準備的配套法律體繫，準確定位“應急醫藥產品的應急預案”，加彊應急醫藥產品的應急信息化管理，建設應急醫藥產品的快速調劑和使用機製。
목적：대미국류행병화재해성응급준비계렬법안중미국식품약품감독관리국(FDA)직능정위진행분석，위아국정부부문적응급직능설계제공삼고。방법：채취법안내용분석법，료해FDA재응급의약산품준비중적직능정위。결과：FDA재의약산품응급준비적근본직능시촉진돌발사건중응급의약산품적개발화사용적가획득성，포괄발포의약산품적응급지도화안전경시신식，부책수권의약산품긴급사용권、연장의약산품보존기한급예치직능。결론：응중시국가급응급준비공작，완선응급준비적배투법률체계，준학정위“응급의약산품적응급예안”，가강응급의약산품적응급신식화관리，건설응급의약산품적쾌속조제화사용궤제。
Objective:To analyze FDA’s functions according to the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) and other laws of emergency preparation in US, in order to provide reference for the emergency function allocation of Chinese government. Methods:The contents of a series of laws of medical countermeasures (MCMs) released by US government were analyzed to understand the roles and functions of FDA in the emergency preparation of MCMs. Results: The essential function of FDA in MCMs emergency preparation is to promote the development and availability of the emergency MCMs. Speciifc measures include the responsibility for authorization of emergency guidance and safety warning information issued, emergency use authorization of MCMs,and extension of expiration dating of MCMs and Pre-Positioning Authority. Conclusion:The great importance of the national emergency preparedness should be attached. Some measures should be taken to improve our legal system of emergency preparedness, to accurately position "emergency preparedness of MCMs", and to strengthen the information dissemination of emergency management of MCMs and the construction of inventory system of MCMs.
