文章摘要
杨建红,李洁,杨柳,沈梦娟,张象麟.美国紫皮书制度研究与构建我国“生物制品已上市产品目录集”必要性及可行性探讨[J].中国药事,2019,33(9):966-971
美国紫皮书制度研究与构建我国“生物制品已上市产品目录集”必要性及可行性探讨
Study on Purple Book of the United States and Discussion on the Necessity and Feasibility of Establishing Catalogue of Listed Biological Products in China
投稿时间:2019-08-01  
DOI:10.16153/j.1002-7777.2019.09.001
中文关键词: 紫皮书  生物制品  上市产品目录集
英文关键词: purple book  biological products  catalogue of listed biological products
基金项目:
作者单位E-mail
杨建红 沈阳药科大学亦弘商学院, 北京 100010  
李洁 辉瑞投资有限公司, 北京 100027  
杨柳 辉瑞投资有限公司, 北京 100027  
沈梦娟 沈阳药科大学亦弘商学院, 北京 100010  
张象麟 沈阳药科大学亦弘商学院, 北京 100010 zhangxianglin@yeehongedu.cn 
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中文摘要:
      目的:对美国FDA紫皮书制度进行研究,结合我国生物制品监管现状与发展,探讨构建我国"生物制品已上市产品目录集"的必要性和可行性。方法:文献研究和对比研究法。结果:对美国紫皮书的内容和作用、美国紫皮书的制度支持及其关键要素进行了研究,在此基础上分析我国"生物制品已上市产品目录集"构建的必要性和可行性。结论:我国现阶段构建"生物制品已上市产品目录集"已具备一定的实施基础,具有可行性和必要性。
英文摘要:
      Objective:To discuss the necessity and feasibility of establishing a catalogue of listed biological products in China by studying the purple book of FDA of the United States and the current situation and development of the regulation of biological products in China. Methods:Literature review and comparative study were used. Results:Content and function, system support and key elements of the purple book of the United States were studied. The necessity and feasibility of establishing a "catalog of listed biological products" in China were analyzed. Conclusion:It is necessary and feasible to establish a catalogue of listed biological products in China due to certain implementation basis.
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