摘要
药品不良反应评价体系是目前上市药品再评价的重要渠道;现存的药品不良反应评价体系存在一些不合理之处,包括评价主体任职资格的缺陷、评价客体难以把握以及药品不良反应责任承担等问题。据此,我国有必要完善药品不良反应评价体系,建立补偿机制。
The evaluation system of drug adverse reactions is an important channel for re - evaluation of listed drugs. However, unreasonable points were found in the present evaluation system, including the defects of evaluatorg certification, object evaluated difficult to control and hard to decide.who should take the responsibility for the adverse drug reactions occurred. Therefore, the evaluation system for adverse drug reactions should be improved, and to set up a relief system for victims.
出处
《中国药事》
CAS
2007年第1期31-32,56,共3页
Chinese Pharmaceutical Affairs
关键词
药品不良反应
评价体系
法律责任
adverse drug reactions
evaluation system
law responsibility