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| 我国药品不良反应监测体系建设有关制度研究 | |
| 引用本文： | 公培献,孔庆衍,周勇,田月洁,黄传海,谢彦军,黄琳,冯巧巧,吴桂芝. 我国药品不良反应监测体系建设有关制度研究[J]. 中国药物警戒, 2009, 6(2): 74-79 |
| 作者姓名： | 公培献 孔庆衍 周勇 田月洁 黄传海 谢彦军 黄琳 冯巧巧 吴桂芝 |
| 作者单位： | 1. 山东省食品药品监督管理局,山东,济南,250013 2. 山东省药品不良反应监测中心,山东,济南,250013 3. 国家食品药品监督管理局药品评价中心,北京,100045 |
| 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. |
| 摘 要： | 通过研究国内外药品不良反应监测体系建设的发展规律和现状，分析我国药品不良反应监测体系建设存在的问题，从制度层面探讨加强药品不良反应监测体系建设的思路。药品不良反应监测在我国药品安全监管工作中发挥了重要作用，应从法律法规层级进一步强化药品不良反应监测的制度化管理，建设省级以下药品不良反应监测机构，完善我国药品不良反应监测体系。 |
| 关 键 词： | 药品不良反应监测 体系建设 制度 研究 |
| 修稿时间： | |
Research on the Related Institution in the Construction of the Adverse Drug Reaction Monitoring System in China |
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| GONG Pei-xian,KONG Qing-yan,ZHOU Yong,TIAN Yue-jie,HUANG Chuan-hai,XIE Yan-jun,HUANG Lin,FENG Qiao-qiao,WU Gui-zhi. Research on the Related Institution in the Construction of the Adverse Drug Reaction Monitoring System in China[J]. Chinese JOurnal of Pharmacovigilance, 2009, 6(2): 74-79 | |
| Authors: | GONG Pei-xian KONG Qing-yan ZHOU Yong TIAN Yue-jie HUANG Chuan-hai XIE Yan-jun HUANG Lin FENG Qiao-qiao WU Gui-zhi |
| Affiliation: | 1Shandong Food and Drug Administration(Shandong Jinan 250013, China) 2Shandong Center for ADR Monitoring (Shandong Jinan 250013, China) 3enter for Drug Reevaluation, SFDA (Beijing 100045, China) |
| Abstract: | Through studying the development laws and the status quo of the adverse drug reaction （ADR） monitoring system at home and abroad, analyzed the problems in the construction of ADR monitoring system and explored the method to strengthen the ADR monitoring system at the institution level. ADR monitoring has played an important role in Chinese drug safety supervision, the institu- tionalization of management for ADR monitoring system should be further strengthened through laws and regulations. The ADR monitoring institution under the provincial level should be constructed to improve the ADR monitoring system. |
| Keywords: | adverse drug reaction （ADR）monitoring system construction institution research |
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