| 以部分疫苗为例分析我国预防用生物制品的改良情况 |
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| 引用本文： | 刘志磊,李洁,高恩明,李小芳,杨建红,张辉.以部分疫苗为例分析我国预防用生物制品的改良情况[J].中国药事,2020,34(1):1-4. |
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| 作者姓名： | 刘志磊 李洁 高恩明 李小芳 杨建红 张辉 |
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| 作者单位： | 国家药品监督管理局药品审评中心, 北京 100038,辉瑞投资有限公司, 北京 100010,国家药品监督管理局药品审评中心, 北京 100038,泰州医药高新技术产业园区新药申报服务中心, 泰州 225300,沈阳药科大学亦弘商学院, 北京 100027,国家药品监督管理局, 北京100037 |
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| 摘 要： | 目的：以百日咳疫苗、人用狂犬病疫苗的改良情况为例，分析监管政策对预防用生物制品技术改良的影响。方法：通过数据分析和文献研究，对我国已批准疫苗的技术改良情况进行分析。结果：技术改良是促进疫苗产业发展的重要手段。结论：监管机构需要通过政策的引导和鼓励促进疫苗的技术改良。
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| 关 键 词： | 疫苗 技术改良 监管 百日咳疫苗 人用狂犬病疫苗 政策 |
| 收稿时间： | 2019/10/29 0:00:00 |
Analysis of the Improvement of Biological Products for Prevention in China Taking Some Vaccines as an Example |
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| Liu Zhilei,Li Jie,Gao Enming,Li Xiaofang,Yang Jianhong and Zhang Hui.Analysis of the Improvement of Biological Products for Prevention in China Taking Some Vaccines as an Example[J].Chinese Pharmaceutical Affairs,2020,34(1):1-4. |
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| Authors: | Liu Zhilei Li Jie Gao Enming Li Xiaofang Yang Jianhong and Zhang Hui |
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| Institution: | Center for Drug Evaluation, NMPA, Beijing 100038, China,Pfizer Investment Co., Ltd., Beijing 100010, China,Center for Drug Evaluation, NMPA, Beijing 100038, China,New Drug Application Sevice Center of Taizhou Medical New & Hi-tech Industrial Development Zone, Taizhou 225300, China,Yeehong Business School of Shenyang Pharmaceutical University, Beijing 100027, China and National Medical Products Administration, Beijing 100037, China |
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| Abstract: | Objective: To review the influence of regulatory policies on technical improvement of biological products for prevention taking the improvement of pertussis vaccine and human rabies vaccine as an example. Methods: The technical improvements in approved vaccines in China were analyzed through data analysis and literature research. Results: Technical improvement is an important means to promote the development of the vaccine industry. Conclusion: Regulatory authority should promote technical improvement of vaccines through policy guidance and encouragement. |
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| Keywords: | vaccine technical improvement regulatory pertussis vaccine human rabies vaccine policies |
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