摘要
目的:研究河北省药品上市许可持有人(MAH)药物警戒工作的进展,为MAH开展药物警戒活动提供借鉴和参考。方法:采用回顾分析法和比较分析法,结合河北省2019年和2021年药物警戒年度报告,对我省MAH药物警戒工作进展情况进行分析。结果:与2019年度相比,2021年度设置药物警戒专门机构的MAH占比由94.25%增至97.48%;配备专职人员的MAH占比由85.06%增至91.60%;药物警戒管理制度齐全的MAH占比由28.74%增至65.55%;自主收集报告的MAH由46家增至61家;发现风险数量由28个增至207个;启动的上市后安全性研究由16项增至47项。结论:河北省MAH药物警戒体系日趋完善,仍有多方面尚待改进。建议国家药监部门推进药物警戒法律法规体系建设,省级药品监管监测部门加强监督检查,贯彻落实相关政策的培训指导,MAH认真学习GVP等技术性指导文件,提升药物警戒能力,持续规范推进GVP实施,保障药物警戒活动有效运行。
Objective:To study the development of pharmacovigilance(PV)work of drug marketing authorization holder(MAH)in Hebei province,and provide references for PV activities of MAH.Methods:Based on PV annual report of Hebei province in 2019 and 2021,the development of PV work were analyzed by retrospective analysis and comparative analysis.Results:Compared with 2019,the proportion of MAH with PV specialized institutions increased from 94.25% to 97.48%,the proportion of MAH with full-time staff increased from 85.06% to 91.60%,the proportion of MAH with complete PV management system increased from 28.74% to 65.55%,the number of MAH that could self-collect reports increased from 46 to 61,the number of risk identified increased from 28 to 207,the number of initiated post-market safety studies increased from 16 to 47.Conclusion:The PV system of MAH in Hebei province has been gradually completed,based on which many aspects of it still needed to be improved.It was suggested to promote the development of PV laws and regulations system by the national medical products administration,implement the training of relevant policies by provincial drug regulatory and monitoring agencies,carefully studied guideline on good pharmacovigilance practice(GVP)by MAH,so as to improve the ability of PV,continuously implement GVP,and ensure the effective activities of PV.
作者
郭莎莎
王冰
王芳
GUO Sha-sha;WANG Bing;WANG Fang(Center for ADR Monitoring of Cangzhou,Cangzhou 061000,China;Center for Pharmacovigilance of Hebei,Shijiazhuang 050090,China)
出处
《中国药物应用与监测》
CAS
2023年第1期63-65,71,共4页
Chinese Journal of Drug Application and Monitoring
基金
2021年度河北省市场监督管理局科技计划项目(2021YJ16)。
关键词
药品上市许可持有人
药物警戒
进展
质量管理规范
Drug marketing authorization holder
Pharmacovigilance
Progress
Quality management specification
