中国药物警戒 ›› 2025, Vol. 22 ›› Issue (3): 282-285.
DOI: 10.19803/j.1672-8629.20240394

• 法规与管理研究 • 上一篇    下一篇

《药物警戒质量管理规范》的药品上市许可持有人符合性评估方法研究

刘颖1, 熊舜禹, 熊慧瑜1, 蔡飞1, 徐梦丹2, 王青3,4, 任韡3, 许燕1,*   

  1. 1广东省药品不良反应监测中心,广东 广州 510080;
    2广东药科大学药学院,广东 广州 510006;
    3清华大学药物警戒信息技术与数据科学创新中心,北京 100084;
    4清华海峡研究院药物警戒信息技术与数据科学研究中心,福建 厦门 361015
  • 收稿日期:2024-06-17 出版日期:2025-03-15 发布日期:2025-03-17
  • 通讯作者: *许燕,女,博士,药品不良反应监测。E-mail：20480419@qq.com
  • 作者简介:刘颖,女,博士,药品不良反应监测。△为并列第一作者。
  • 基金资助:
    2022年广东省药品监督管理局科技创新项目（2022YDZ08）

Methods for Assessment of MAH Compliance with GVP

LIU Ying1, XIONG Shunyu,XIONG Huiyu1, CAI Fei1, XU Mengdan2, WANG Qing3,4, REN Wei3, XU Yan1,*   

  1. 1Center for ADR Monitoring of Guangdong, Guangzhou Guangdong 510080, China;
    2School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou Guangdong 510006, China;
    3Research Center for Pharmacovigilance IT and Data Science, Tsinghua University, Beijing 100084, China;
    4Pharmacovigilance Research Center for information Technology and Data Science, Cross-Strait Tsinghua Research Institute, Xiamen Fujian 361015, China
  • Received:2024-06-17 Online:2025-03-15 Published:2025-03-17

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摘要： 目的 探讨药品上市许可持有人（简称“持有人”）《药物警戒质量管理规范》（GVP）符合性评估方法,根据业务应用场景设计信息化评估工具,为监督管理部门高效开展药物警戒评估及持有人自评提供参考。方法 针对药物警戒监管工作和持有人GVP合规性的需求,构建持有人GVP符合性评估指标体系,通过数据分析技术建立持有人药物警戒能力信息化画像模型,形成GVP符合性评估方法,进一步研究设计成信息化工具,在广东省内开展试点应用。结果 形成299条评估指标要点和指标评分评级标准,建立评估指标体系和评估方法。结合实际工作开展情况,设计信息化工具,探索构建持有人药物警戒能力信息化画像模型。结论 持有人GVP符合性评估方法及信息化工具的建立,为科学监管和指导持有人提升药物警戒能力提供新工具的参考。

关键词: 药品上市许可持有人, 药物警戒质量管理规范, 符合性评估, 药物警戒, 信息化工具, 科学监管

Abstract: Objective To explore the methods for assessment of marketing authorization holders’ (MAHs) compliance with Good Pharmacovigilance Practice (GVP) and to design an informatized assessment tool according to applications in businesses so as to provide a reference for regulators’ efficient assessment of pharmacovigilance and for self-assessment by MAHs. Methods A system of indexes for assessment of MAHs’ compliance with GVP was developed as required by pharmacovigilance and related assessment. An informatized profiling model for MAHs’ pharmacovigilance was established via data analysis technology before the assessment methods were developed that were to be designed into assessment tools used across the province on a trial basis. Results Two hundred and ninety-nine key points of indexes for assessment and rating standards were identified, so the system and methods for assessment evaluation were established. Based on the actual operations, an informazed tool was devised and an informatized profiling model for assessment was established. Conclusion The establishment of methods for assessment of GVP compliance and informatized tools provides an innovative approach by which MAHs can improve their pharmacovigilance.

Key words: Marketing Authorization Holder(MAH), Good Pharmacovigilance Practice(GVP), Assessment of Compliance, Pharmacovigilance, Informatized Tool, Effective Supervision

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