| 我国实行药品风险管理制度基本策略研究 |
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| 引用本文： | 杨华,金丹,杨月明,王嘉仡,魏晶. 我国实行药品风险管理制度基本策略研究[J]. 中国药物警戒, 2009, 27(3): 129-133 |
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| 作者姓名： | 杨华 金丹 杨月明 王嘉仡 魏晶 |
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| 作者单位： | 辽宁省药品不良反应监测中心,辽宁,沈阳,110003 |
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| 基金项目： | 国家食品药品监督管理局《药品管理法》修订项目 |
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| 摘 要： | 通过对美国、欧盟药品风险管理制度的法规体系、指南体系以及我国药品风险及风险管理现状的分析，阐述了通过立法将风险管理理念引入药品安全性监管工作，建立可行的风险管理制度体系是降低药品风险的必要措施。建议我国应通过完善法律法规体系、技术指南体系，强力推行在药品监督管理部门监管下，药品生产企业、药品经营企业、医疗机构承担药品风险管理责任、实行药品风险管理规范的风险管理制度。
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| 关 键 词： | 药品 风险管理 策略 |
| 收稿时间： | 2009-01-12 |
| 修稿时间： | |
Research on Strategy of Drug Risk Management System in China |
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| YANG Hua,JIN Dan,YANG Yue-ming,WANG Jia-yi,WEI Jing. Research on Strategy of Drug Risk Management System in China[J]. Chinese JOurnal of Pharmacovigilance, 2009, 27(3): 129-133 |
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| Authors: | YANG Hua JIN Dan YANG Yue-ming WANG Jia-yi WEI Jing |
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| Affiliation: | Liaoning Center for ADR Monitoring (Liaoning Shenyang 110003, China) |
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| Abstract: | This article reviews current regulations and guidance system of drug risk management in America and EU and studies drug risk characteristics in China. It concludes that it is the essential to reduce risk by establishing risk management system. It suggested that we should improve regulations and technical guidance system, and enact standard of risk management practice. At the same time, the policy of risk management system in which pharmaceutical enterprises, medical and health agencies undertake the responsibility of risk management under the supervision of drug administration department should be carried out. |
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| Keywords: | drug risk management strategy |
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