关于加强我国疫苗临床试验监管的思考(上)  

Considerations for strengthening the supervision on clinical trials of vaccine in China(PartⅠ)

作　　者：高荣[1] 李见明[1] 

机构地区：[1]国家食品药品监督管理局药品认证管理中心,北京100061

出　　处：《中国新药杂志》2012年第16期1861-1863,共3页Chinese Journal of New Drugs

摘　　要：疫苗临床试验的安全性较为特殊,如严重不良反应多为急性过敏性反应、严重不良事件常见群体性心因性反应和偶合反应等;另外,其受试者权益保护问题尤为值得监管部门关注。本文阐述了我国疫苗临床试验运行情况和监管模式,分析了其监管模式形成的原因,指出在疫苗临床试验新的发展形势下,监管部门需要探索疫苗临床试验监管的新模式,以提高监管效能。The safety of the vaccine clinical trials has its special characteristics. For example, the serious adverse reaction is often acute allergic reactions, and the serious adverse events are more common in mass psycho- genie reactions and coupling reactions. In addition, protecting the rights and interests of its subjects is particularly worthy of regulatory attention. This paper described the operation and regulatory model of the clinical trials on vac- cines in China, and analyzed the reasons for the formati situation of the development of vaccine clinical trials, th on of the regulatory model. We pointed out that in the new e regulatory authorities need to explore new regulatory rood- el of vaccine clinical trials to improve the effectiveness of supervision

关 键 词：疫苗 临床试验 监管 

分 类 号：R186[医药卫生—流行病学]