中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 504-506.
DOI: 10.19803/j.1672-8629.2021.06.02

• 《药物警戒质量管理规范》研究与实践专栏 • 上一篇    下一篇

药物警戒制度下制药集团公司建立药物警戒体系的思考

江丹娜1, 赖文健2, 赵希平1, 刘颖3, 许燕3,*   

  1. 1广东众生药业股份有限公司,广东 东莞 523000;
    2中山大学公共卫生学院,广东 广州 510080;
    3广东省药品不良反应监测中心,广东 广州 510080
  • 收稿日期:2021-04-20 出版日期:2021-06-15 发布日期:2021-07-02
  • 通讯作者: *许燕,女,博士,药品不良反应监测与评价。E-mail：20480419@qq.com
  • 作者简介:江丹娜,女,本科,执业药师,药品不良反应监测。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017ZX09101001-001-003）

Thoughts on the Establishment of Pharmacovigilance Systems in Pharmaceutical Group Companies under Pharmacovigilance Systems

JIANG Danna1, LAI Wenjian2, ZHAO Xiping1, LIU Ying3, XU Yan3,*   

  1. 1Guangdong Zhongsheng Pharmaceutical Co., Ltd, Dongguan Guangdong 523000, China;
    2School of Public Health, Sun Yat-sen University, Guangzhou Guangdong 510080, China;
    3Center for ADR monitoring of Guangdong, Guangzhou Guangdong 510080, China
  • Received:2021-04-20 Online:2021-06-15 Published:2021-07-02

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摘要： 目的 对构建集团化药物警戒体系的关键问题进行思考,为制药集团公司构建集团化的药物警戒体系提供参考。方法 结合《药物警戒质量管理规范》（GVP）及药品上市许可持有人建立药物警戒体系的经验,探讨集团化药物警戒体系的优势、相关条件及可能存在问题,并对如何构建集团化药物警戒体系提出建议。结果 构建集团化的药物警戒体系有利于集团公司实现资源利用最大化,促进集团药物警戒专业水平的提升。结论 为迎接GVP实施带来的挑战,集团公司可结合自身情况考虑建立集团化药物警戒体系。

关键词: 制药集团, 药物警戒体系, 药物警戒质量管理规范

Abstract: Objective To provide a reference for pharmaceutical groups to build a group pharmacovigilance system through reflecting on the key issues in building a group pharmacovigilance system. Methods Based on the good pharmacovigilance practices (GVP) and the experience of marketing authorization holders in establishing pharmacovigilance systems, the advantages, conditions and possible problems of a group pharmacovigilance system were discussed and suggestions on how to build a group pharmacovigilance system were made. Results The construction of a group pharmacovigilance system is conducive to maximizing resource utilization and improving the professional level of the group pharmacovigilance. Conclusion To meet the challenges brought by the implementation of GVP, pharmaceutical groups may consider establishing a group pharmacovigilance system based on their own situation.

Key words: pharmaceutical group, pharmacovigilance system, good pharmacovigilance practices

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