浅谈药品说明书和标签的监管-中国药事.PDF

2010 2412 1151 潘 伟( , 430012) : 把 药品说明书和标签管理规定 落实到药品质量监督管理中, 促进医药行业健康快速发 思考探讨药品说明书和标签存在的问题及原因 加大药品说明书和标签的监管力 度是保证人民群众用药安全有效的有力措施之一; 同时是对抽样人员药品质量监督检查工作能力的验证 : 药品; 说明书; 标签; 监管 : R95 : :(2010) Discussionon Supervisionof Package Insert andLabel of Drug Pan Wei (Wuhan Institute for Food and Drug Control, Wuhan 430012) ABSTRACT: Objective T o implement T he Package Insert and Label of Drug Regulations in the supervision and management of drug quality, and promote healthy and rapid development of the pharmaceutical industry. ethodsT hinking and discussing the problems and causes of package insert and label of drug. Results and Conclusion Increasing the supervision on package insert and label of drug is one of effective measures to ensure the safety of peoples drug use. t the same time, it is to verify the work ability for the sampling staff in drug quality supervision and inspection work. KEYWORDS: drug; package insert; label; supervise [4] 1 14 [ 1] 11 : : , , , , , , 2 [2] 12 21 , : ! , , , 22 23 ∀; : 24 / , ! ∀ [3] 13 25 , : , , ; T el: Email: panwei_ 8888@ yahoocomcn 1152 2010 24 12