《药物警戒质量管理规范》对我国构建药物警戒制度的意义

Significance of Good Pharmacovigilance Practice in the Construction of China Pharmacovigilance System

目的探讨《药物警戒质量管理规范》(Good Pharmocovigilance Practice,GVP)对我国建立药物警戒制度的意义。方法回顾GVP出台的背景,研究GVP在药品安全监管领域中地位,概述GVP核心要旨,探讨GVP在我国建立药物警戒制度中的作用。结果和结论GVP的颁布和实施迈出了中国构建药物警戒制度的第一步,对我国全面推进药物警戒制度有着重大意义和深远影响。

Objective To explore the significance of Good Pharmacovigilance Pracetice(GVP)in constructing the Pharmacovigilance System of China.Methods review the background of GVP,study its status in the field of drug safety supervision,summarize its core and gist,discuss its role in the Pharmacovigilance System,and analyze the significance of its introduction.Results and Conclusion the promulgation and implementation of GVP is the first step in the construction of China Pharmacovigilance System,which has great significance and far-reaching influence.