摘要
我国对药品再评价的认识是逐步发展的过程。再评价制度应当包括药品使用的安全性和有效性评价以及质量控制的评价。药品再评价制度应规范上市后研究、信息与文献的收集管理及信息发布管理,并参考美国FDA信息管理建立完善我国药品安全信息发布制度。应将再评价与药品再注册相衔接,涵盖生产环节与使用环节,从而构成药品上市前、后的全面监管,并随着再注册的循环进行而持续,形成一个螺旋上升的过程。
The realization of the drug reevaluation system is developing gradually in China. The drug reevaluation system should include the evaluation of rational and effective use of drug, and the evalua-tion of drug quality control. The post-market reevaluation, management of the information and liter-ature and publication of the information should be standardized.The publication system of drug safety information should be established according to the FDA information management system in USA. The drug re-registration system depends on the whole process of drug production, use and reevalua-tion. The pre-market and post-market monitoring forms a circle and it will play an important role in drug quality control.
出处
《中国药物警戒》
2008年第2期93-96,100,共5页
Chinese Journal of Pharmacovigilance
关键词
药品再评价
药品再注册
风险管理
安全信息
drug reevaluation
drug re-registration
risk management
safety information
