摘要
"齐二药"假药事件、鱼腥草注射液事件、欣弗药品不良事件,2006年3个重大的药品安全事件,暴露出我国药品行政监督管理存在的种种问题:重视认证式管理,忽视日常监督检查;假药、劣药概念尚需推敲;行政失职难以界定;药品审评中行政自由裁量权缺乏制约等。问题的解决,不但需要加强监管、完善立法,更要切断药品监管机构与制药企业之间的利益链条,使其真正履行"把关人"职责。
Three serious drug injury events in 2006, namely Qi-Er-Yao counterfeit drug event, Herba Houttuyniae injection event,adverse drug event of Xinfu injection, exposed certain problems in drug supervision and regulation. Drug regulatory agency attached importance to administration of certification, but neglected regular supervision and inspection. Definition of counterfeit drugs and substandard drugs needs to be revised. It is difficult to confirm breach of administrative duty. Administrative discretion in drug evaluation lacks restriction. To resolve these problems, not only strengthening of supervision and perfecting of legislation are needed, but the interest chain between the drug supervision agency and pharmaceutical companies also should be cut off,so that the agency can actually fulfill its role as a ＂gatekeeper＂.
出处
《药学服务与研究》
CAS
CSCD
2007年第4期241-244,共4页
Pharmaceutical Care and Research
关键词
药品安全
药物批准
立法
药物
监管
药品
药物利用评审
drug safety
drug approval
legislation,drug
regulation,drug
drug utilization review
