MedDRA在中国药品监测应用实施的现状分析及建议

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

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。

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.