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

doi:10.19803/j.1672-8629.2021.08.13

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (8): 763-765.
DOI: 10.19803/j.1672-8629.2021.08.13

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

田春华, 刘巍, 刘翠丽, 侯永芳, 王丹

国家药品监督管理局药品评价中心,北京 100022

收稿日期:2020-11-10 出版日期:2021-08-15 发布日期:2021-08-17
作者简介:田春华,女,硕士,副主任药师,药品不良反应监测与评价、非处方药技术评价。

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

TIAN Chunhua, LIU Wei, LIU Cuili, HOU Yongfang, WANG Dan

Center for Drug Reevaluation, NMPA, Beijing 100022, China

Received:2020-11-10 Online:2021-08-15 Published:2021-08-17

摘要/Abstract

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。

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

Abstract: 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.

Key words: post-marketing monitoring of drugs, MedDRA, ICH

中图分类号:

R951

田春华, 刘巍, 刘翠丽, 侯永芳, 王丹. 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[J]. 中国药物警戒, 2021, 18(8): 763-765.

TIAN Chunhua, LIU Wei, LIU Cuili, HOU Yongfang, WANG Dan. Progress in Implementation of ICH M1 in Post-marketing Monitoring of Drugs in China[J]. Chinese Journal of Pharmacovigilance, 2021, 18(8): 763-765.

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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

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