假劣药品的风险来源与监管措施研究.PDFVIP

682 中国药事 2015 年 7 月 第 29 卷 第 7 期 ·监督管理 · 假劣药品的风险来源与监管措施研究 1 2 1* 韩若斯 , ，杨悦 （1. 沈阳药科大学工商管理学院，沈阳 110016；2. 中国食品药品检定研究院， 北京 100050） 摘要 目的：针对当前药品市场上假劣药品的风险来源，分析原因，在现有监管措施的基础上提出合理化 建议。方法：收集 2005 年至 2014 年期间性质恶劣、危害范围广的代表性假劣药品案件，运用鱼骨分析法 分析其根源。同时，分析现有监管措施的有效性和适宜性。结果与结论： 目前，监管部门主要通过完善 标准和管理制度、开展监督检查和专项行动，以及创新监管措施来遏制制售假劣药品的行为。建议进一 步完善假劣药品概念、建立药品企业责任义务制约机制、引入风险管理理念，从根本上遏制制售假劣药 品的行为。 关键词： 典型案例；假劣药；风险；鱼骨图；监管 中图分类号：R95 文献标识码：A 文章编号： 1002-7777(2015)07-0682-05 doi:10.16153/j.1002-7777.2015.07.002 Analysis of Sources of Counterfeit and Inferior Drugs and Supervision Measures Han Ruosi1, 2, Yang Yue1* (1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. National Institutes for Food and Drug Control, Beijing 100050, China) Abstract Objective: To analyze the risk sources and causes of counterfeit and inferior drugs in the market, and put forward reasonable suggestions based on the current regulation measures. Methods: The representative cases of counterfeit and inferior drugs from the year 2005 to 2014 were collected, the sources of those drugs were analyzed by fishbone diagram. Meanwhile, the effectiveness and suitability of the current supervision measures were analyzed. Results and Conclusion: At present, producing and selling counterfeit and inferior drugs is restricted by the authorities mainly through improvement of standards and management, implementation of supervision and inspection activities and innovation of regulatory measures. It is suggested the authorities further perfect the definition of counterfeit and inferior drugs, establish a restricting system of enterprise responsibilities and obligations and introduce the concept of risk management so as to curb the behavior of producing and selling counterfeit and inferior drugs. Keywords: typical cases; counterfeit and inferior drugs;