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tan feng xian guan li zai yao pin jian guan zhong de ying yong
Author(s): 
Pages: 756-757
Year: Issue:  12
Journal: Qilu Pharmaceutical Affairs

Abstract:  近年来,我国相继发生的"齐二药"、"欣弗"等药害事件,使药品安全性问题越来越受到社会各界的关注,事实表明,药品监管部门仅仅通过药品审批、日常监管、药品不良反应监测等环节不足以保证药品的安全性,必须探索药品监管的规律,建立更为有效的药品管理机制和制度,来确保药品的安全.经过多年的探索,我局在药品监管中引入风险管理的理念,建立起了品种质量基础上的市场安全风险管理体系,实现多环节、全方位、立体式覆盖,...
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