| 我国已上市治疗用生物制品整体情况分析 |
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| 引用本文： | 张辉,辛中帅,邵颖,张彦彦,张象麟. 我国已上市治疗用生物制品整体情况分析[J]. 中国药事, 2019, 33(9): 972-981 |
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| 作者姓名： | 张辉 辛中帅 邵颖 张彦彦 张象麟 |
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| 作者单位： | 国家药品监督管理局, 北京 100037,复星医药万新医药科技(苏州)有限公司, 苏州 215123,沈阳药科大学亦弘商学院, 北京 100010,沈阳药科大学亦弘商学院, 北京 100010,沈阳药科大学亦弘商学院, 北京 100010 |
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| 摘 要： | 目的：梳理我国已上市治疗用生物制品的整体情况，提炼出存在的问题，为行业提供参考信息，同时为完善我国治疗用生物制品注册管理制度体系提供数据支持。方法：基于我国已上市治疗用生物制品的数据，进行统计分析和对比分析。结果：对我国已批准治疗用生物制品信息进行了整合，并从批准上市产品的发展历程、创新程度、技术类别等不同维度进行了全方位深入分析。结论：与发达国家相比，我国治疗用生物制品的研发和产业化相对较晚，市场规模较为有限，但增速显著高于全球水平。
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| 关 键 词： | 生物制品 注册管理制度 已上市药品信息 创新性分析 发展历程 |
| 收稿时间： | 2019-08-01 |
Analysis of Overall Situation of Listed Biological Products for Therapeutic Use in China |
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| Zhang Hui,Xin Zhongshuai,Shao Ying,Zhang Yanyan and Zhang Xianglin. Analysis of Overall Situation of Listed Biological Products for Therapeutic Use in China[J]. Chinese Pharmaceutical Affairs, 2019, 33(9): 972-981 |
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| Authors: | Zhang Hui Xin Zhongshuai Shao Ying Zhang Yanyan Zhang Xianglin |
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| Affiliation: | National Medical Products Administration, Beijing 100037, China,Vonsun Pharmatech Co Ltd, Suzhou 215123, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100010, China,School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100010, China and School of Yeehong Business, Shenyang Pharmaceutical University, Beijing 100010, China |
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| Abstract: | Objective:To analyze the overall situation of the listed biological products for therapeutic use in China, find out existing problems, provide references for the industry and provide data support for improving the registration management system of biological products for therapeutic use in China. Methods:Based on the dat a of the listed biological products for therapeutic use in China, statistical analysis and comparative analysis were carried out. Results:The information on biological products for therapeutic use approved in China was integrated. Different dimensions such as the development history, innovation degree and technology category of approved products were comprehensively and thoroughly analyzed. Conclusion:Compared with developed countries, the research and development, industrialization of biological products for therapeutic use in China are relatively new, and the market scale is not big enough, while the growth rate is significantly higher than that of the global level. |
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| Keywords: | biological products registration management system information of listed drugs innovative analysis development history |
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