摘要
本文根据药品生产企业现场调查结果,针对法律法规赋予药品生产企业的责任和义务、生产企业药品不良反应数据反馈利用、药品定期安全性更新报告等工作要求,论述药品不良反应监测对于企业风险管理的重要性。目的在于查找药品生产企业在药品上市后安全性监测方面存在的问题,探索监管部门和生产企业运用药品不良反应监测方法对药品进行生产全周期安全管理的方式方法,提高生产企业及时发现和解决药品安全性风险问题的能力。
Based on the on-site investigation results of pharmaceutical manufacturing enterprises, the importance of adverse drug reaction monitoring for enterprise risk management is discussed in view of the responsibilities and obligations entrusted to pharmaceutical manufacturing enterprises by laws and regulations, the feedback utilization of adverse drug reaction data from manufacturing enterprises and the work requirements for periodic safety update report of drugs in this paper. The purpose is to find out the problems existing in the safety monitoring of pharmaceutical manufacturing enterprises after the listing of drugs and to explore ways and means for the supervision departments and pharmaceutical manufacturing enterprises to conduct full-cycle safety management of drugs by the adverse drug reaction monitoring method to improve the ability of manufacturing enterprises to discover and solve drug safety risks in time.
作者
方延学
马丹
刘宇琴
Fang Yan-xue;Ma Dan;Liu Yu-qin(Gansu Provincial Center for Monitoring Adverse Drug and Medical Device Reactions,Gansu Lanzhou 730070,China)
出处
《中国执业药师》
CAS
2018年第12期153-155,共3页
China Licensed Pharmacist
关键词
药品不良反应
风险管控
积极作用
存在问题
Adverse Drug Rreactions
Risk Management and Control
Positive Effect
Problem
