| 从药物警戒和药品不良反应监测制度探讨《药品管理法》尚待完善的有关内容 |
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| 引用本文： | 董铎,吴桂芝,田春华,陈易新,李馨龄,张承绪,武志昂. 从药物警戒和药品不良反应监测制度探讨《药品管理法》尚待完善的有关内容[J]. 中国药物警戒, 2009, 6(2): 65-68 |
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| 作者姓名： | 董铎 吴桂芝 田春华 陈易新 李馨龄 张承绪 武志昂 |
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| 作者单位： | 国家食品药品监督管理局药品评价中心,北京,100045 |
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| 基金项目： | 课题来源：国家食品药品监督管理局《药品管理法》修订项目;课题负责人：王者雄,国家食品药品监督管理局药品安全监管司;课题执行负责人：武志昂,国家食品药品监督管理局药品评价中心. |
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| 摘 要： | 本文通过对我国药品不良反应监测体系建设现状、药品生产企业和医疗机构在药物警戒和药品不良反应监测中的地位和责任、相关主体的法律责任以及药品不良反应损害救济制度等的研究，强调《药品管理法》应明确药品评价技术机构的法律地位、强化药品生产企业的法律责任、建立药品不良反应损害救济制度，并对此提出了具体的修改建议。
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| 关 键 词： | 药物警戒 药品不良反应 药品管理法 |
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Suggestions on Drug Administration Law of People's Republic of China Amendment: Researching the System of Pharmacovigilance and Adverse Drug Reaction Monitoring |
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| DONG Duo,WU Gui-zhi,TIAN Chun-hua,CHEN Yi-xin,LI Xin-ling,ZHANG Cheng-xu,WU Zhi-ang. Suggestions on Drug Administration Law of People's Republic of China Amendment: Researching the System of Pharmacovigilance and Adverse Drug Reaction Monitoring[J]. Chinese JOurnal of Pharmacovigilance, 2009, 6(2): 65-68 |
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| Authors: | DONG Duo WU Gui-zhi TIAN Chun-hua CHEN Yi-xin LI Xin-ling ZHANG Cheng-xu WU Zhi-ang |
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| Affiliation: | Center for Drug Reevaluation, SFDA (Beijing 100045, China ) |
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| Abstract: | This article reviews current organization of adverse reaction monitoring system, roles of drug manufactures, medical and health agencies, legal duty of relevant main bodies and the relief system of adverse drug reactions. It suggested confirming the legal status of the reevaluation institutes, strengthen- ing the legal duty of drug manufactures, establishing the relief system of adverse drug reactions should be added in Drug Administration Law of the People＇s Republic of China and the concrete advices were brought forward. |
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| Keywords: | pharmacovigilance adverse drug reaction monitoring drug administration law of the People＇s Republic of China |
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