| 北京市高风险品种药品生产企业监管问题分析与对策研究 |
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| 引用本文： | 袁林,秦良伟,何鸣.北京市高风险品种药品生产企业监管问题分析与对策研究[J].中国药事,2010,24(1):3-7,10. |
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| 作者姓名： | 袁林 秦良伟 何鸣 |
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| 作者单位： | 北京市药品监督管理局,北京,100053 |
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| 摘 要： | 目的提高北京市高风险品种药品生产企业的监管水平。方法分析了北京市高风险品种药品生产企业存在的主要问题,以及产生这些问题的深层次原因。结果与结论药品注射剂、血液制品、疫苗等是极易引起患者致死致残事故的高风险药品品种,做好高风险品种药品生产企业的监管工作是药品监管的重中之重。目前北京市高风险品种药品的生产质量基本稳定,但总的形势并不容乐观,安全风险依然存在。应当从监管制度、技术、人员等方面采取措施予以完善。
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| 关 键 词： | 高风险品种药品 药品监管 安全风险 风险管理 |
Analysis and Policy Research of the Supervision over Pharmaceutical Manufacturers of High-risk Drugs |
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| Yuan Lin,Qin Liangwei,He Ming.Analysis and Policy Research of the Supervision over Pharmaceutical Manufacturers of High-risk Drugs[J].Chinese Pharmaceutical Affairs,2010,24(1):3-7,10. |
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| Authors: | Yuan Lin Qin Liangwei He Ming |
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| Institution: | Yuan Lin,Qin Liangwei , He Ming(Beijing Drug Administration,Beijing 100053) |
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| Abstract: | Objective To improve the supervision level for pharmaceutical manufacturers of high-risk drugs in Beijing.Methods Analyze the major problems existing in pharmaceutical manufacturers of high-risk drugs in Beijing,as well as deep-seated reasons.Results and Conclusion Poor-quality high-risk drugs including drug injections,blood products and vaccines may easily lead to death and disability.Therefore,the supervision of pharmaceutical manufacturers producing these drugs should be the priority of drug supervision.... |
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| Keywords: | high-risk drugs drug supervision safty risk risk management |
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