文章摘要
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
我国已上市治疗用生物制品问题分析及监管建议
Analysis of the Problems of Listed Biological Products for Therapeutic Use in China and Recommendations for Regulation
投稿时间:2019-08-01  
DOI:10.16153/j.1002-7777.2019.09.003
中文关键词: 生物制品  监管建议  现存问题
英文关键词: biological products  regulatory advice  existing problems
基金项目:
作者单位E-mail
辛中帅 复星医药万新医药科技(苏州)有限公司, 苏州 215123  
张辉 国家药品监督管理局, 北京 100037  
杨建红 沈阳药科大学亦弘商学院, 北京 100010  
张彦彦 沈阳药科大学亦弘商学院, 北京 100010  
邵颖 沈阳药科大学亦弘商学院, 北京 100010 syszyywm@163.com 
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中文摘要:
      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。
英文摘要:
      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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