| 我国已上市治疗用生物制品问题分析及监管建议 |
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| 引用本文： | 辛中帅,张辉,杨建红,张彦彦,邵颖.我国已上市治疗用生物制品问题分析及监管建议[J].中国药事,2019,33(9):982-985. |
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| 作者姓名： | 辛中帅 张辉 杨建红 张彦彦 邵颖 |
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| 作者单位： | 复星医药万新医药科技(苏州)有限公司, 苏州 215123,国家药品监督管理局, 北京 100037,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：对我国已上市治疗用生物制品现状及存在问题进行分析，并在此基础上从鼓励创新、系统构建注册法规等多个角度提出完善监管的建议。方法：基于对我国已上市治疗用生物制品批准情况的深度分析，通过专家咨询，提出建议。结果：治疗用生物制品产业发展迅速，在一定程度上满足了我国公众临床用药的需求，但仍与国际先进水平存在较大差距。结论：从鼓励创新、促进生物类似药发展、完善药品批准文号等方面提出建议。
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| 关 键 词： | 生物制品 监管建议 现存问题 |
| 收稿时间： | 2019/8/1 0:00:00 |
Analysis of the Problems of Listed Biological Products for Therapeutic Use in China and Recommendations for Regulation |
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| Xin Zhongshuai,Zhang Hui,Yang Jianhong,Zhang Yanyan and Shao Ying.Analysis of the Problems of Listed Biological Products for Therapeutic Use in China and Recommendations for Regulation[J].Chinese Pharmaceutical Affairs,2019,33(9):982-985. |
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| Authors: | Xin Zhongshuai Zhang Hui Yang Jianhong Zhang Yanyan and Shao Ying |
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| Institution: | Vonsun Pharmatech Co Ltd, Suzhou 215123, China,National Medical Products Administration, Beijing 100037, 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 current situation and existing problems of listed biological products for therapeutic use in China and put forward suggestions for improving regulation from various aspects such as encouraging innovation and systematically establishing registration regulations. Methods:Suggestions were put forward based on the in-depth analysis of the approval status of the listed biological products for therapeutic use in China as well as through expert consultation. Results:The industry of biological products for therapeutic use has developed rapidly and has met the need of public clinical use of medicines in China to a certain extent. But there is still a large gap with the international advanced level. Conclusion:Suggestions are put forward from the aspects of encouraging innovation, promoting the development of biosimilars, and perfecting the system of drug approval number. |
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| Keywords: | biological products regulatory advice existing problems |
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