药品不良反应报告中《监管活动医学词典》编码相关思考及建议  

Considerations about MedDRA Coding in Adverse Drug Reaction Reports

作　　者：刘翠丽 田春华 夏东胜 朱兰 刘红亮 申长慧 漆燕 王涛 LIU Cuili;TIAN Chuanhua;XIA Dongsheng;ZHU Lan;LIU Hongliang;SHEN Changhui;QI Yan;WANG Tao(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilanle,Beijing 100022,China)

机构地区：[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,北京100022

出　　处：《中国药物警戒》2021年第11期1055-1057,共3页Chinese Journal of Pharmacovigilance

基　　金：重大新药创制国家科技重大专项2017年度(2017ZX09101001-001-003)。

摘　　要：目的介绍我国药品上市后药品不良反应病例报告中《监管活动医学词典》(Medical Dictionary for Regulatory Activities,MedDRA)编码相关思考和建议,以期为我国药品上市许可持有人(简称“持有人”)以MedDRA为标准术语集报告药品不良反应提供参考。方法阐述在药品不良反应报告中做好MedDRA编码的基本条件、应遵循的一般原则及注意事项。结果与结论随着MedDRA在我国的广泛使用,建议相关部门结合维护和支持服务组织(Maintenance and Support Services Organization,MSSO)术语选择相关要求及我国实际情况,发布统一的国内MedDRA使用原则,便于国内用户遵照执行。Objective To make comments on MedDRA coding in case reports of Chinese drugs in order to provide reference for Chinese marketing authorization holders(MAHs)in the process of reporting adverse reactions with the Medical Dictionary for Regulatory Activities(MedDRA)as the standard term set.Methods The essential conditions,general principles and considerations related to MedDRA coding in adverse reaction reports were specified,and recommendations were made on MedDRA coding.Results and Conclusion With the extensive use of MedDRA in China,it is recommended that drug regulatory authorities release unified principles on the use of MedDRA in China in conjunction with the related requirements on term selection by the Maintenance and Support Services Organization(MSSO).

关 键 词：药品不良反应报告 监管活动医学词典 编码 药品上市许可持有人 

分 类 号：R994.11[医药卫生—毒理学]