基因改构减毒活疫苗环境影响分析的考虑  

General consideration for the environmental risk assessment for genetically modified live attenuated vaccines

作　　者：陈庆华[1] 李敏[1] 罗建辉[1] 高恩明[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2016年第5期499-502,共4页Chinese Journal of New Drugs

摘　　要：基因改构减毒活疫苗的活性成分可经受种者排毒后在自然界存活,给生态环境及人类健康带来潜在影响。本文在借鉴美国及欧盟相关环境影响评价指导原则和要求的基础上,针对我国注册申报现状提出对此类疫苗的环境影响评价考虑要点。Active ingredients of genetically modified live attenuated vaccines may be released into the environment by vaccinees thereby causing potentially harmful effects on the ecosystem as well as on human health. In this article,we reviewed the guidelines issued by FDA and EMEA,and proposed the general points to consider when making an environmental risk assessment for genetically modified live attenuated vaccines in China.

关 键 词：基因改构生物体 减毒疫苗 活疫苗 环境影响评价 排放 影响 生态环境 人类健康 

分 类 号：R95[医药卫生—药学]