简化审批 从严管理  

Strict Management with Less Red Tapes in Approval of Drug Clinical Trial

作　　者：于丽[1] 

机构地区：[1]《中国处方药》编辑部

出　　处：《中国处方药》2009年第12期25-27,共3页Journal of China Prescription Drug

摘　　要：发展创新药,积极参加国际多中心试验,加入新药全球同步开发的行列,是大多数业内人士的心声。药物临床试验简化审批、从严管理,让更多的国际多中心试验进入中国,成为这次沙龙达成的共识。The research report of Current Situation and Development of Drug Clinical Trials in China was released,and it caused enthusiastic discussion in the industry. Zhang Wei,director of SFDA Drug Registration Department,said that the Round-table Salon of Innovation and Development of Drug Clinical Trial in China was also a dialogue between researchers and the pharmaceutical industry,such a dialogue and exchange was necessary,with the attention and support from so many professionals,various policies and regulations could be improved more quickly. Strict management with less red tapes in approval of drug clinical trial became the consensus reached in the salon.

关 键 词：审批 管理 多中心试验 药物临床试验 业内人士 创新药 国际 

分 类 号：R95[医药卫生—药学]