由齐齐哈尔第二制药“亮菌甲素事件”引发的思考

On the Event of“Armillarisin A”Made by Qiqihar No.2 Pharmaceutical Co.Ltd.

目的:探讨齐齐哈尔第二制药“亮菌甲素事件”带给我们的思考。方法:从齐齐哈尔第二制药“亮菌甲素事件”出发,分析当前我国药品生产、管理过程中存在的问题,寻找根源。结果与结论:制药企业应重视其社会责任,药品的监督管理不能缺位,应从该事件中吸取教训,从药品生产质量、注册审批、流通秩序、药品不良反应报告等全方位实施有效管理,才能防止类似事件再度发生。

OBJECTIVE：To discuss the thoughts over the event of ＂armillarisin A＂ produced by Qiqihar No.2 Pharmaceutical Co. Ltd.METHODS：Citing the event of ＂armillarisin A＂ produced by Qiqihar No.2 Pharmaceutical Co. Ltd. as example, we analyzed problems occurred in the process of production and management of pharmaceuticals and traced the root causes. RESULTS ＆ CONCLUSIONS：Pharmaceutical enterprises should bear in mind their social responsibility and leave no loophole in the control and supervision of drugs ,they should draw lessons from this event and prevent the similar event from happening again by working out effective measures to tighten controls on the quality of drug production, registering and approval, circulation, ADR reporting, etc.