我国药品上市后监测实施《M1:监管活动医学词典》进展及思考  

Progress in Implementation of ICH M1 in Post-marketing Monitoring of Drugs in China

作　　者：田春华 刘巍 刘翠丽 侯永芳 王丹 TIAN Chunhua;LIU Wei;LIU Cuili;HOU Yongfang;WANG Dan(Center for Drug Reevaluation,NMPA,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品评价中心,北京100022

出　　处：《中国药物警戒》2021年第8期763-765,共3页Chinese Journal of Pharmacovigilance

摘　　要：目的介绍我国药品上市后监测工作中有关国际人用药品注册技术协调会(ICH)等系列指导原则《M1:监管活动医学问典》(MedDRA)的实施进展和推进思路,以期为全面实施MedDRA提供参考。方法阐述MedDRA基本情况,探讨转化实施面临的问题和挑战,以及工作进展和建议。结果与结论MedDRA是目前全球药品监管领域广泛应用的医学术语,实施MedDRA有利于药品上市后监测数据的分享和交换,需结合我国实际情况稳步推进。Objective To report the progress in the implementation of MedDRA during the post-marketing monitoring of drugs in China in order to provide reference for complete implementation of MedDRA.Methods MedDRA was outlined.The problems with and challenges to the implementation and transformation of MedDRA were discussed.Ways to implement MedDRA were recommended.Results and Conclusion MedDRA is a medical term widely used in the field of global drug regulation.The implementation of MedDRA is conducive to the sharing and exchange of post-marketing monitoring data on drugs,but has to be steadily advanced in light of the actual situation in China.

关 键 词：药品上市后监测 监管活动医学词典 国际人用药品注册技术协调会 

分 类 号：R951[医药卫生—药学]