文章摘要
徐莉,郭中平.国内外生物制品通用名命名体系的比较与分析[J].中国药事,2018,32(4):502-509
国内外生物制品通用名命名体系的比较与分析
Comparison and Analysis of Generic Naming System for Biological Products at Home and Abroad
投稿时间:2016-10-27  
DOI:10.16153/j.1002-7777.2018.04.013
中文关键词: 通用名称  国际药品通用名称  美国药品通用名称  英国药品通用名称  中国药品通用名称  命名原则
英文关键词: generic name  International nonproprietary name  United States adopted names  British approved name  Chinese approved drug name  naming principles
基金项目:国家重大新药创制《生物类似药技术评价相关支撑体系的研究》专项课题“生物类似药命名原则的研究和建立”资助项目(编号2015ZX09501008-003)
作者单位E-mail
徐莉 舒泰神(北京)生物制药股份有限公司, 北京 100176  
郭中平 国家药典委员会, 北京 100061 guozhongping@chp.org.cn 
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中文摘要:
      目的:为修订我国生物制品通用名称命名原则及明确命名工作程序和技术要求提供科学合理的技术参考和建议。方法:采用文献资料法,对国际药品通用名称、美国通用药品名称、英国药品通用名称及中国药品通用名的通用名称命名体系的命名原则、申报要求等进行全面比较和分析。结果与结论:概述了各通用名称命名体系、命名原则、命名工作程序及技术要求等的异同点,为我国生物制品通用名称命名原则的修订工作奠定了基础。
英文摘要:
      Objective: To provide scientific and reasonable technical reference and suggestions for revising the naming principles for generic name of biological products in China and clarifying its procedures and related technical requirements. Methods: The general principles and requirements for application of the generic naming systems, such as generic naming system of International Nonproprietary Name, United States Adopted Name, British Approved Name and Chinese Approved Drug Name were comprehensively compared and analyzed using the method of literature review. Results and conclusion: The similarities and differences between the naming principles, working procedures and technical requirements of above naming systems were clarifed, which laid a foundation for the revision of the naming principles of the Chinese Approved Drug Name for biological products.
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