摘要
分析我国药品生产企业个例药品不良反应监测能力不足、上报意识不强等现状,借鉴美国、欧盟药品生产企业收集个例药品不良反应方法和经验,探讨既符合我国法律法规要求,又适应国内药品生产企业实际情况,能够切实可行的提高生产企业个例药品不良反应收集水平的对策。
This paper analyzed the present status of insufficient monitoring capacity and lack of a sense of ADR reporting in domestic pharmaceutical manufaCTuring enterprises,and by drawing on relevant good praCTices in EU and USA,this paper proposed a new methodology to improve the ADR case reporting level for domestic pharmaceutical manufaCTurers. The proposed methods are in comformity to the requirements of the laws and regulations in China,and are also praCTical to implement for the industries as well.
作者
杨月明
杨红玉
廖剑波
王丹
YANG Yueming;YANG Hongyu;LIAO Jianbo;WANG Dan(Liaoning Center for Drug and Device Evaluation and Monitoring,Shenyang,Liaoning 110036,China;Center for Drug Reevaluation,China Food and Drug Administration,Beifing 100022,China)
出处
《安徽医药》
CAS
2018年第10期2019-2021,共3页
Anhui Medical and Pharmaceutical Journal
关键词
药物副反应报告系统
制药工业
登记
问题解决
Adverse drug reaCTion reporting systems
Drug industry
Registries
Problem solving
