浅析“欣弗事件”——药品质量管理认识  

An analysis of the Xinfu event —— knowledge about medicine quality management

作　　者：魏桂梅[1] 张金甲 

机构地区：[1]甘肃省中医院白银分院,甘肃兰州730900

出　　处：《中医临床研究》2015年第25期123-125,共3页Clinical Journal Of Chinese Medicine

摘　　要："欣弗"事件造成全国不良反应事件报告81例,涉及10个省份,其中3例死亡。该药品事件暴露出我国药品生产企业、药品市场秩序的混乱,相关监管措施的漏洞以及相关法律法规的缺失。由"欣弗"事件,我们应实施合理有效的药品质量管理措施,保障用药安全。Xinfu event caused 81 cases of the adverse recations, involving 10 provinces, with 3 cases of death. The medicine event exposed the confusion of the pharmaceutical production enterprises, the medicine market, the relevant regulatory measures and the lack of relevant laws and regulations. By the Xinfu event, we should carry out medicine quality management measures, ensure the medicine safety.

关 键 词：“欣弗”事件 生产环节 药品质量 质量管理 GMP认证 药管监督 

分 类 号：R2-03[医药卫生—中医学]