| 建立我国突发事件应急状态下的医疗产品紧急使用授权机制探讨 |
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| 引用本文： | 王刚,杨建红,苏岭,邵颖,陈震,高凯,张彦彦,陈江鹏,张象麟.建立我国突发事件应急状态下的医疗产品紧急使用授权机制探讨[J].中国药事,2020,34(3):254-259. |
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| 作者姓名： | 王刚 杨建红 苏岭 邵颖 陈震 高凯 张彦彦 陈江鹏 张象麟 |
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| 作者单位： | 沈阳药科大学亦弘商学院, 北京 100055,沈阳药科大学亦弘商学院, 北京 100055,沈阳药科大学亦弘商学院, 北京 100055;礼来亚洲基金, 上海 200021,意大利纳维诺医药科技集团, 意大利 IT-20014,郑州大学药物研究院, 郑州 450001,上海大学生命科学学院, 上海 200444,沈阳药科大学亦弘商学院, 北京 100055,沈阳药科大学亦弘商学院, 北京 100055,沈阳药科大学亦弘商学院, 北京 100055 |
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| 摘 要： | 目的： 通过对美国FDA的紧急使用授权（Emergency Use Authorization，EUA）制度进行研究，结合我国国情，探讨在我国建立医疗产品紧急使用授权机制。方法： 文献研究、专题访谈。结果与结论： 紧急使用授权制度有别于我国现有的特别审评程序，对于应对突发事件应急状态下所需药物的评估和使用授权，提高药物使用的安全性、时效性、可及性及合规性具有重要意义。本研究初步提出了在我国建立医疗产品紧急使用授权机制的考虑要点，包括建立紧急使用授权制度的必要性、制度的基本定位、上位法的支持、制度构建的关键要素、配套的技术指南及其他需要关注的问题。
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| 关 键 词： | 紧急使用授权 医疗产品 突发事件应急状态 新冠病毒肺炎 |
| 收稿时间： | 2020/2/28 0:00:00 |
On Establishing Emergency Use Authorization System of Medical Products under Emergency State in China |
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| Wang Gang,Yang Jianhong,Su Ling,Shao Ying,Chen Zhen,Gao Kai,Zhang Yanyan,Chen Jiangpeng and Zhang Xianglin.On Establishing Emergency Use Authorization System of Medical Products under Emergency State in China[J].Chinese Pharmaceutical Affairs,2020,34(3):254-259. |
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| Authors: | Wang Gang Yang Jianhong Su Ling Shao Ying Chen Zhen Gao Kai Zhang Yanyan Chen Jiangpeng and Zhang Xianglin |
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| Institution: | School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100055, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100055, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100055, China;Lilly Asia Ventures, Shanghai 200021, China,Nerviano Medical Sciences Group, IT-20014, Italy,Institute of Drug Discovery and Development, Zhengzhou University, Zhengzhou 450001, China,School of Life Science, Shanghai University, Shanghai 200444, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100055, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100055, China and School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100055, China |
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| Abstract: | Objective: To discuss establishment of the Emergency Use Authorization (EUA) system of medical products in China based on the study of EUA of U.S. FDA and situation of China. Methods: The methods of literature review and interviews were used. Results and Conclusion: The EUA system is different from current special review procedures specified in provisions for drug registration. The EUA system is thereby of great importance for the evaluation and authorization, as well as improvement of the safety, timeliness, accessibility and regulatory compliance of the medical products urgently needed in case of public health emergencies. The main considerations for establishing EUA system of medical products in China were put forward in the study, such as the necessity of establishing the EUA system; the fundamental roles of the EUA system; support from higher-level laws; the key elements to establish the EUA system; the technical guidelines to support the EUA system; and other considerations related to the EUA system. |
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| Keywords: | emergency use authorization medical products emergency state corona virus disease 2019(COVID-19) |
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