中国药物警戒 ›› 2023, Vol. 20 ›› Issue (10): 1090-1094.
DOI: 10.19803/j.1672-8629.20230508

• 上市后监测方法与评估体系研究专栏 • 上一篇    下一篇

药品上市许可持有人药物警戒工作评估指标体系的探索

贾晋生1, 王青2, 刘红亮1, 侯永芳1,*   

  1. 1国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100076;
    2清华大学药物警戒信息技术与数据科学创新中心,北京 100084
  • 收稿日期:2023-08-18 出版日期:2023-10-15 发布日期:2023-10-16
  • 通讯作者: *侯永芳,男,正高级工程师,药品不良反应监测。E-mail：houyongfang@cdr-adr.org.cn
  • 作者简介:贾晋生,男,本科,工程师,药品不良反应监测。
  • 基金资助:
    国家重点研发计划（2020YFC2005501）; 国家药品监督管理局中国药品监管科学研究行动计划重点项目（CDRZ 20193027）

Evaluation index system of MAH pharmacovigilance work

JIA Jinsheng1, WANG Qing2, LIU Hongliang1, HOU Yongfang1,*   

  1. 1Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    2Research Center for Pharmacovigilance IT and Data Science, Tsinghua University, Beijing 100084, China
  • Received:2023-08-18 Online:2023-10-15 Published:2023-10-16

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摘要： 目的 探索量化评价药品上市许可持有人（简称“持有人”）药物警戒工作质量的方法,支持基于大数据的科学监管工作开展。方法 采用层次分析法（AHP）,从持有人不良反应/不良事件的监测与报告、风险识别与评估、上市后安全性研究、药品安全风险控制等相关方面进行了分解细化,形成了持有人药物警戒工作评估指标体系,并设计了基于此指标体系的数据分析信息化平台。结果 筛选出准则层6个指标、子准则层25个指标、指标层85个指标,并确定出评价体系的各级指标权重值。结合实际业务开展情况和真实世界数据基础,探索设计持有人药物警戒工作评估信息化平台。结论 持有人药物警戒工作评估指标体系和信息化平台为探索持有人药物警戒工作评估智能化提供了参考。

关键词: 层次分析法, 药品上市许可持有人, 药物警戒, 评价指标, 信息化平台, 药品不良反应

Abstract: Objective To explore methods to quantitatively evaluate the pharmacovigilance evaluation work of marketing authorization holder(MAH) and support the development of scientific supervision work based on big data. Methods The analytic hierarchy process(AHP) method was used to decompose and detail ADR/ADE monitoring and reporting, risk identification and evaluation, post-market safety research, drug safety risk control and other related aspects, forming the MAH pharmacovigilance work evaluation index system. A data analysis information platform based on this index system was designed. Results 6 indicators of the criterion layer, 25 indicators of the sub-criterion layer and 85 indicators of the lowest layer are selected, and the weight values of each indicator of the evaluation system are determined. Based on the actual business situation and real world data, an information platform for MAH pharmacovigilance work evaluation was explored and designed. Conclusion The evaluation index system and information platform of holder pharmacovigilance laid the foundation for the intelligent evaluation of MAH pharmacovigilance work.

Key words: analytic hierarchy process(AHP), marketing authorization holder(MAH), pharmacovigilance, evaluation index, information platform, adverse drug reaction

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