浅谈WHO国家疫苗监管体系评估及其上市许可板块要求  

A brief discussion on requirements of the marketing authorization and license activities function from National Regulatory Authority Assessment of WHO

作　　者：李敏[1] 孔漫[1] 常卫红[2] 高恩明[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038 [2]国家食品药品监督管理局药品注册司,北京100053

出　　处：《微生物学免疫学进展》2012年第3期67-72,共6页Progress In Microbiology and Immunology

摘　　要：通过卫生组织国家疫苗监管体系(National Regulatory Authority)评估是一个国家疫苗具备参与联合国全球采购资格的必要条件。本文对WHO国家疫苗监管体系评估整体加以简述,重点对上市许可板块指标进行归纳,通过探讨WHO国家疫苗监管体系评估上市许可部分的管理理念,以期为疫苗监管相关部门加强自身管理提升监管质量和效率有所提示。It is essential to pass through the national regulatory authority （NRA） assessment of WHO for the country to be qualified for vaccine supply to the United Nations agencies. Though the introduction of the NRA system and the discussion on the market authorization and licensing activities function, this paper is drafted to hint the think points of WHO, which may be benefit for the quality management system of our national regulatory system.

关 键 词：疫苗 国家监管体系评估 上市许可 质量管理体系 

分 类 号：R392[医药卫生—免疫学]