上海市药物临床试验机构现况及其监管的思考  

Current status and administration for drug clinical trial institutions in Shanghai

作　　者：张清[1] 孙轶康[1] 

机构地区：[1]上海市食品药品监督管理局认证审评中心,上海200020

出　　处：《中国新药与临床杂志》2009年第6期469-471,共3页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：药物临床试验是新药研发过程中的一个重要环节,其操作的规范程度直接关系着药物研发的成败。本文通过对上海市药物临床试验机构分布及近年申报新药主要涉及专业领域的分析,探索加强药物临床试验监管的思路。Clinical trial is an important link in the chain of new drug research and development （ R＆D）. The results of drug R＆D directly depend on the extent of standardization of clinical trial. This paper explored the measures for the supervision and control of drug clinical trials according to the distribution of drug clinical trial institutions and the professional field related to new drug registration in recent years.

关 键 词：临床试验 立法 药物 法规 药品注册 现场核查 监督管理 

分 类 号：R954[医药卫生—药学]