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从药用胶囊铬超标系列事件浅析如何建立我国药品安全快速预警与应急处置机制
Simple Analysis on How to Establish Rapid Alert System and Emergency Response Mechanism for Drug Safety Based on the Events of Medicinal Capsules with Excessive Chromium
投稿时间:2017-10-17  修订日期:2017-11-09
DOI:
中文关键词:  药用胶囊铬超标系列事件  预警  应急处置
英文关键词:Series events of medicinal capsules with excessive chromium  Early alert  Emergency response
基金项目:
作者单位
张秋 陈慧 姚立辉 国家食品药品监督管理总局高级研修学院 北京 100073 
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中文摘要:
      摘 要为进一步守住药品安全防线,做好药品安全事件快速预警和应急处置,有效防范和应对药品安全事件提供参考。回顾药用胶囊铬超标系列事件的处置过程,通过剖析药用胶囊铬超标系列事件的特点,探讨我国药品安全应急处置与预警机制。建立药品安全突发事件监测机制、风险分析与评估机制、程序启动机制、危机终止及善后评估机制、适当的舆情引导机制、明确药品安全突发事件处置中快速检测的法律地位是完善药品安全突发事件快速预警与应急处置的有效手段,可为我国的药品安全监管提供必要保障。
英文摘要:
      ABSTRACTTo further hold drug safety defense, rapid alert and emergency response should be done well for drug safety events in order to provide reference for effective prevention and response to drug safety incidents. The disposal process of the series events of medicinal capsules with excessive chromium was reviewed, and the features were analyzed to explore the emergency response and alert system for drug safety in China. To set up drug safety emergency monitoring mechanism, risk analysis and assessment mechanisms, procedures startup mechanism, crisis ending and follow up assessment mechanism, appropriate public opinion guide mechanism, and a clear legal status of rapid test in the disposal of drug safety incidents are effective means to improve drug safety rapid alert and emergency response, which can provide necessary guarantees for drug safety and regulation.
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