摘要
该文以《药物警戒质量管理规范》(GVP)出台为背景,探究持有人实施药物警戒制度的重要意义,总结GVP对持有人提出的新制度要求,分析持有人实施药物警戒面临的挑战。实施药物警戒制度,最大限度地降低药品安全风险,保护和促进公众健康,是现代药企必须牢固树立的观念,也是其立业之根本。
Based on the good pharmacovigilance Practice(GVP),the significance of implementing pharmacovigilance institution in enterprises was discussed,the new requirements of GVP for enterprises were summarized,and the challenges faced by enterprises in implementing pharmacovigilance were analyzed.Implementing pharmacovigilance system to minimize the drug safety risk and promoting public health were the concept that modern pharmaceutical enterprises must firmly establish and the foundation of their business.
作者
王丹
王涛
夏旭东
孙阳
胡增峣
WANG Dan;WANG Tao;XIA Xudong;SUN Yang;HU Zengyao(National Center for ADR Reevaluation,National Medical Products Administation,Beijing 100022,China;Center for ADR Reevaluation of Henan,Zhengzhou 450004,China;Department of Drug Regulation of National Medical Products Administation,Beijing 100037,China)
出处
《医药导报》
CAS
北大核心
2021年第10期1303-1306,共4页
Herald of Medicine
基金
国家科技重大专项项目(2017ZX09101001-001-003)。
关键词
药物警戒
药物警戒质量管理规范
药品不良反应监测
Pharmacovigilance
Good pharmacovigilance practice
Adverse drug reaction monitoring
