| 中药上市后评价的机遇与挑战 |
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| 引用本文： | 杜晓曦,宋海波,任经天,杨乐,郭晓昕,逄瑜. 中药上市后评价的机遇与挑战[J]. 中国中药杂志, 2014, 39(18): 3427-3429 |
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| 作者姓名： | 杜晓曦 宋海波 任经天 杨乐 郭晓昕 逄瑜 |
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| 作者单位： | 国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 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（2011ZX09304-08） |
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| 摘 要： | 上市后评价是对药品临床应用的风险、效益等进行全面、系统评估的过程,科学系统的上市后评价结果,既可为中药临床安全用药提供数据支持,也是监管部门制订风险管理措施的可靠依据。随着人民群众治疗及预防疾病的需求不断增加,中药的应用更加广泛,安全性问题也日益凸显。如何早期发现中药安全风险信号,有针对性的开展中药上市后评价研究,及时控制风险,已成为中医药产业发展中的挑战性问题。
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| 关 键 词： | 中药 上市后评价 不良反应监测 |
| 收稿时间： | 2014-07-25 |
Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine |
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| DU Xiao-xi,SONG Hai-bo,REN Jing-tian,YANG Le,GUO Xiao-xin and PANG Yu. Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine[J]. China Journal of Chinese Materia Medica, 2014, 39(18): 3427-3429 |
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| Authors: | DU Xiao-xi SONG Hai-bo REN Jing-tian YANG Le GUO Xiao-xin PANG Yu |
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| Affiliation: | Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China |
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| Abstract: | Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry. |
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| Keywords: | traditional Chinese medicine post-marketing evaluation adverse drug reaction monitoring |
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