我国药品召回过程存在的问题与对策分析  

On Problems and Countermeasures of the Drug-recall Process

作　　者：赵剑锋 王红云 郭颖 张昊[3] 周舰 祝建中 

机构地区：[1]北京市延庆县食品药品监督管理局,北京102100 [2]国家中药品种保护审评委员会,北京100070 [3]国家食品药品监督管理总局高级研修学院,北京100073

出　　处：《中国药事》2016年第1期50-53,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:为完善我国药品召回管理体系提供参考。方法:结合药品召回现场监督检查,分析药品召回过程中存在的问题。结果与结论:我国药品召回渠道仍不畅通,在基层卫生医疗机构可能存在召回盲点。建议健全药品电子监管法律制度,完善药品电子监管追溯系统,充分利用药品大数据,保证药品的有效召回。Objective： To provide references for the improvement of drug-recall system in China. Methods： The problems were analyzed on the basis of daily inspection of drug-recall. Results and Conclusion： Drug-recall channels in our country are still not smooth, community medical and health institutions in rural areas may refuse to recall the drugs. Government should make full use of the extensive data about drug to ensure that the medicines are recalled effectively, and establish a legal system of electronic supervision to perfect the electronic traceable system of drug.

关 键 词：药品召回 制度 电子监管 

分 类 号：R95[医药卫生—药学]