| 美国FDA关于企业开展药品上市后研究和临床试验指南简介 |
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| 引用本文： | 董铎,孙利华,王丹. 美国FDA关于企业开展药品上市后研究和临床试验指南简介[J]. 中国新药杂志, 2012, 0(9): 960-963 |
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| 作者姓名： | 董铎 孙利华 王丹 |
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| 作者单位： | 沈阳药科大学工商管理学院;国家食品药品监督管理局药品评价中心 |
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| 摘 要： | 为完善我国药品上市后研究工作,本文对美国FDA官方网站及相关国内外文献进行了检索,汇总分析显示:FDA指南明确了生产企业开展上市后研究和临床试验的背景、要求、方法及程序等操作细则。该指南可供我国借鉴参考,但尚需要结合国情,进一步明确内容与范畴,并在实践中逐渐形成具有中国特色的药品上市后研究技术指南。
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| 关 键 词： | 美国 企业 药品不良反应 上市后研究 指南 |
FDA Guidance for Industry Postmarketing Studies and Clinical Trials in US |
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| DONG Duo,SUN Li-hua,WANG Dan. FDA Guidance for Industry Postmarketing Studies and Clinical Trials in US[J]. Chinese Journal of New Drugs, 2012, 0(9): 960-963 |
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| Authors: | DONG Duo SUN Li-hua WANG Dan |
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| Affiliation: | 1 School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China; 2 Center For Drug Reevaluation,SFDA,Beijing 100045,China) |
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| Abstract: | In order to provide reference for postmarketing study in China,the official website of FDA and the related domestic and foreign literatures were looked up.The summary shows that the FDA Guidance clearly interprets the details of performing postmarketing studies and clinical Trials by industries,such as background,requirement,methods,and procedures.The Guidance can be referenced by China,but our realistic situation should be considered,and the scope and content should be further defined.The specific guidance on postmarketing study in China should be set up in practice. |
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| Keywords: | the United State industry adverse drug reaction postmarketing study guidance |
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