中国药物警戒 ›› 2024, Vol. 21 ›› Issue (7): 746-751.
DOI: 10.19803/j.1672-8629.20240103

• 中国药物警戒制度发展研究专栏 • 上一篇    下一篇

MedDRA在中国药品监测应用实施的现状分析及建议

朱彦1, 李庆娜2, 朱兰3, 谢江安4, 姚克宇1, 黄光瑞5, 杨啸林6#, 关健7,*   

  1. 1中国中医科学院中医药信息研究所,北京 100700;
    2中国中医科学院西苑医院临床药理研究所,北京 100091;
    3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;
    4重庆邮电大学生命健康信息科学与工程学院,重庆 400065;
    5北京中医药大学生命科学学院,北京 102488;
    6中国医学科学院基础医学研究所,北京协和医学院基础学院,北京 100005;
    7中国医学科学院北京协和医院,国家人口健康科学数据中心(临床医学),北京 100730
  • 收稿日期:2024-02-22 出版日期:2024-07-15 发布日期:2024-07-31
  • 通讯作者: * 关健,女,博士,教授,医学科学数据共享与治理。E-mail: gjpumch@126.com;#为共同通信作者。
  • 作者简介:朱彦,男,博士,副研究员,中医药信息学。
  • 基金资助:
    国家重点研发计划（2021YFC2302001）; 国家自然科学基金资助项目（82174534）; 中国医学科学与健康科技创新工程项目（2021-I2M-1-057）; 中国中医科学院科技创新工程重大攻关项目（CI2021A04704）; 中央级公益性科研院所基本科研业务费专项资金资助（ZZ13-YQ-126）; 中国中医科学院基本科研业务费自主选题项目（ZZ150314）; 国家药品监督管理局药品评价中心委托课题（BVCM-2021-KJ-YJY001）

Current situation and suggestions concerning the implementation of MedDRA in drug monitoring in China

ZHU Yan1, LI Qingna2, ZHU Lan3, XIE Jiang’an4, YAO Keyu1, HUANG Guangrui5, YANG Xiaolin6#, GUAN Jian7,*   

  1. 1Institute of Information on Traditional Chinese Medicine, CACMS, Beijing 100700, China;
    2Institute of Clinical Pharmacology, Xiyuan Hospital of China, Academy of Chinese Medical Sciences, Beijing 100091, China;
    3Center for Drug Reevaluation, NMPA/NMPA, Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    4College of Bioinformatics, Chongqing University of Posts and Telecommunications, Chongqing 400065, China;
    5School of Life Sciences, Beijing University of Traditional Chinese Medicine, Beijing 102488, China;
    6Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, Beijing 100005, China;
    7Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, The National Population Health Data Center (Clinical Medicine), Beijing 100730, China
  • Received:2024-02-22 Online:2024-07-15 Published:2024-07-31

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摘要： 目的 介绍《监管活动医学词典》（MedDRA）在我国药品监管应用实施中的问题和挑战,以期为更好地实施MedDRA提供参考和建议。方法 阐述MedDRA的基本情况,系统分析探讨产品本身的特点、管理机制、用户培训和用户社区建设等方面的问题与挑战,并从完善管理机制、扩展中文版结构、构建编码共享案例库、持续审查和改进MedDRA中文版、补充和完善定义、扩展中医部分内容等方面针对性地提出建议。结果与结论 在各方努力下,MedDRA的引入、推广和落地实施已经取得了很好的开局。由于MedDRA产品本身的特点、现有机制等因素,带来了若干问题和挑战,需要各方力量协调一致,共同努力改善和克服相关问题和挑战,更快更好地实现与国际接轨和互认升级,推动中国创新药高质量发展。

关键词: 监管活动医学词典, 术语集, 药品, 上市后, 监测

Abstract: Objective To point out the problems with and challenges to the implementation of the Medical Dictionary for Regulatory Activities (MedDRA) in drug monitoring in China in order to provide reference for applications of MedDRA. Methods MedDRA was outlined. Issues and challenges facing the product itself, management mechanisms, training of users, and construction of the community of users were analyzed. Countermeasures were recommended, such as improving management mechanisms, expanding the Chinese version, building a shared coding case database, continuous review and improvement of the Chinese version of MedDRA, supplementing definitions, and increasing the content of traditional Chinese medicine. Results and Conclusion With collaborated efforts, the introduction, popularization, and implementation of MedDRA started smoothly. Due to such factors as the characteristics of MedDRA products and existing management mechanisms, there were several issues and challenges. All parties concerned needed to coordinate and work together to address related issues and challenges to make MedDRA compatible with internationally-accepted practices and achieve mutual recognition, and to promote the high-quality development of innovative drugs in China.

Key words: MedDRA, terminology, drug, postmarketing, surveillance

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