从“齐二药”、“欣弗”等药害事件分析药品生产和监管环节存在的问题  

Analysis of the Existing Problems in the Drug Manufacturing and Drug Supervision and Management From the "Qi Er Yao" Counterfeit Event and "Xin Fu" Drug Accidents

作　　者：陈晓莉[1] 

机构地区：[1]国家食品药品监督管理局药品认证管理中心,北京100061

出　　处：《中国药事》2008年第10期871-873,共3页Chinese Pharmaceutical Affairs

摘　　要：通过对"齐二药"假药事件和"欣弗"等药害事件的总结,进一步讨论药品生产企业和监督管理环节存在的问题,分析假药事件和药害事件发生的原因,追根溯源,借鉴发达国家防御药害事件的先进经验,探讨如何解决药害事件频发和保障公众用药安全的有效途径。ABSTRACT The existing problems in the drug manufacturing and drug supervision and management were discussed through the summary of the ＂Qi Er Yao＂ counterfeit event and ＂Xin Fu＂ drug accidents etc. Via analyzed the root causes and learned the advanced experience from developed countries in the prevention of such drug accidents, they were discussed how the frequency of the drug accident was reduced and what was the effective approach to ensure the safety for public drug using. This article hope to cause the attention of both drug manufacturer and supervision departments that they could get lessons and try to prevent the recurrence of the similar case.

关 键 词：“齐二药” “欣弗” 药害事件 监督管理 

分 类 号：R954[医药卫生—药学]