全生命周期药物警戒体系和药物警戒技术实施现状调研  

Investigation on the Implementation Status of Pharmacovigilance System and Pharmacovigilance Technology Throughout Drug Whole Lifecycle

作　　者：管绯 高建 张艳 GUAN Fei;GAO Jian;ZHANG Yan(Pving.Co.,Ltd.,Beijing 100120,China;Eucure Technology(Beijing)Co.,Ltd,Beijing 100022,China;Pierre Fabre(Shanghai)Medical Co.,Ltd,Beijing 100024,China)

机构地区：[1]北京信安佳康医疗科技有限公司,北京100120 [2]祐和医药科技(北京)有限公司,北京100022 [3]皮尔法伯(上海)医疗科技有限公司,北京100024

出　　处：《中国医药导刊》2023年第12期1200-1206,共7页Chinese Journal of Medicinal Guide

摘　　要：目的:探索现阶段医药企业药物警戒体系建立情况和药物警戒活动实际情况,重点关注药物临床试验期间药物警戒风险识别与评估方面的能力、经验和亟需解决的主要问题,旨在为医药企业和药监部门进一步改善药物警戒体系的合规质量、药物警戒活动的具体实施效果提供借鉴和参考。方法:结合我国药物警戒法规监管要求和药物警戒体系阶段发展特点,提炼药物警戒相关的关键信息,设计调查问卷,问卷范围涵盖医药企业药物警戒相关工作的专业性从业人员,基于调研结果总结分析我国医药企业全生命周期药物警戒体系和药物警戒技术实施现状。结果:调研结果显示,我国医药企业(包括处在临床研发和/或药品上市后阶段企业)正逐步建立和完善药物警戒体系。目前面临问题主要集中在安全性数据分析和配适的方法、数据挖掘和展示,包括可视化技术的应用。结论:现阶段,我国医药企业迫切需要健全系统分析安全性信息的策略和方法,以及利用新技术、采用恰当的统计方法完善前瞻性安全性信息分析计划,更好地对所收集到的安全性数据进行基于科学证据基础上的信号检测、风险识别与评估,进一步支持药品安全管理决策。Objective:To explores the compliance status of the pharmacovigilance system and the implementation status of pharmacovigilance activities of pharmaceutical enterprises at this stage,focusing on the capacity,experience and key issues that need to be urgently addressed in the identification and assessment of pharmacovigilance risks during drugs clinical trials,in order to provides a valuable reference for pharmaceutical companies and regulatory departments to further improve the compliance quality of pharmacovigilance systems and the specific implementation effects of pharmacovigilance activities.Methods:Combined with the regulatory requirements of pharmacovigilance and the characteristics of the development stage of pharmacovigilance system in China,the questionnaire was designed including the key information related to pharmacovigilance and carried out.The scope of the questionnaire covers the pharmaceutical industry professionals who work on drug alert in the enterprise.Based on the results of the survey,the author summarize and analyze the current situation of the whole life cycle pharmacovigilance system and pharmacovigilance technology in pharmaceutical enterprises.Results:The questionnaire results show that the pharmaceutical enterprises in China(including those in the stage of clinical development and/or post-marketing)are gradually in the process of configuration and perfection in the construction of pharmacovigilance system.At present,the main problems mainly focus on the methodology of safety information analysis and adaptation,data mining and data presentation,including the application of visualization technology.Conclusion:On the basis of basically pharmacovigilance compliance,there are urgent needs for pharmaceutical enterprises in China to improve the ability of systematic analysis strategies and analysis methods of safety information,and to improve safety information analysis plans under the guidance of new technologies and statistical methods,so as to better identify detect signals,and evaluate the

关 键 词：药物警戒体系 安全性信息 信号检测 问卷调查 

分 类 号：R95[医药卫生—药学]