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本文采用比较研究方法,对美国药品不良反应/事件监测Medwatch计划与我国的药品不良反应/事件监测体系进行了比较,重点对比了两套监测体系特点以及报告表的模块设计和报告内容。以完善我国药品不良反应/事件(ADR/ADE)监测制度和报告表设计提供参考和建议。
In this paper, a comparative study was conducted to compare the Medwatch program of ADR / event monitoring with the ADR / event monitoring system in China, focusing on the features of two sets of monitoring systems and the module design and reporting content of the report forms. To improve China’s ADR / ADE monitoring system and report form design provide a reference and recommendations.