| 药品不良反应报告和监测管理办法解读及对中药不良反应监测的意义 |
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| 引用本文： | 王丹,杜晓曦.药品不良反应报告和监测管理办法解读及对中药不良反应监测的意义[J].中国中药杂志,2012,37(18):2686-2688. |
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| 作者姓名： | 王丹 杜晓曦 |
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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;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： | 国家"重大新药创制"科技重大专项(2009ZX09502-030)"中药上市后评价关键技术研究" |
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| 摘 要： | 新修订的《药品不良反应报告和监测管理办法》于2011年7月1日起实施,这是我国药品不良反应监测工作中最重要的一部法规。该文通过对《办法》内容进行深入的解读,并剖析新办法对中药不良反应监测的指导意义,使新办法的主要修订内容更加明晰,指导中药不良反应监测工作的开展。
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| 关 键 词： | 管理办法 药品不良反应监测 不良反应报告 |
| 收稿时间： | 2012/7/15 0:00:00 |
Interpretation of adverse drug reaction reporting and monitoring and significance of traditional Chinese medicine adverse drug reaction monitoring |
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| WANG Dan and DU Xiao-xi.Interpretation of adverse drug reaction reporting and monitoring and significance of traditional Chinese medicine adverse drug reaction monitoring[J].China Journal of Chinese Materia Medica,2012,37(18):2686-2688. |
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| Authors: | WANG Dan and DU Xiao-xi |
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| Affiliation: | Center for Drug Evaluation, State Food and prug Administration, Beijing 100045, China;Center for Drug Evaluation, State Food and prug Administration, Beijing 100045, China |
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| Abstract: | The newly revised Regulations for the Administration of Adverse Drug Reaction Reporting and monitoringhas been implemented since July 1, 2011. It is the most important regulation on adverse drug reaction (ADR) monitoring. This article will intensively read the regulation and analysis its significance on the traditional Chinese medicine adverse reaction monitoring, so as to make the revised content more clear and guide the ADR monitoring working better. |
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| Keywords: | management method adverse drug reaction monitoring adverse drug reaction report |
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