监管活动医学词典术语集简介与应用  

An introduction to the Medical Dictionary for Regulatory Activities and its use

作　　者：Anna C Zhao-Wong 朱丽琳 Anna C Zhao-Wong;ZHU Lilin(MedDRA MSSO,McLean,Virginia 22102,USA;MedDRA MSSO,Beijing 100013,China)

机构地区：[1]MedDRA维护和支持服务组织,美国弗吉尼亚州麦克莱恩市22102 [2]MedDRA维护和支持服务组织,北京100013

出　　处：《中国药物警戒》2022年第1期74-78,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的介绍人用药品技术要求国际协调理事会(Technical Requirements for Pharmaceuticals for Human Use,ICH)主办下编制的国际医学术语集—监管活动医学词典(Medical Dictionary for Regulatory Activities,MedDRA)及其在监管领域的应用。方法描述20世纪90年代全球药品监管领域对国际标准术语集的需求,阐释MedDRA的结构特征和维护模式,历数MedDRA成长和发展的里程碑,包括近期面对COVID-19疫情挑战所采取的行动,并展望MedDRA未来的发展。结果和结论由于药品研发领域的监管活动亟需一个国际标准术语集,ICH发起创办了MedDRA。MedDRA用于医学产品的注册、文件记录、安全监测与监督,从临床试验到上市后监测,贯穿于产品开发周期中的各个阶段。MedDRA的结构特征和维护模式是按照其使用目的设计开发的。自启动以来,MedDRA作为一个用户驱动的术语集,在维护和支持服务组织(Maintenance and Support Services Organization,MSSO)的精心管理下扩充了术语体量和范围,以满足用户的需求以及不断发展的监管报告要求,并跟上医学进展的步伐。Objective To introduce the Medical Dictionary for Regulatory Activities(MedDRA)Terminology,a medical terminology developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)and the use of MedDRA in the regulatory area.Methods The need for an international standard terminology in the 1990s was traced,the structure and maintenance of MedDRA were illustrated,the milestones of MedDRA’s growth and development were listed,including its recent actions to meet the challenges of the COVID-19 pandemic,and the future developments of MedDRA were outlined.Results and Conclusion MedDRA by ICH resulted from the need for an international standard terminology that could meet the regulatory needs in pharmaceutical research and development.MedDRA has been used in the registration,documentation,safety monitoring and oversight of medicinal products through each phase of the pipeline,from clinical trials to post-marketing surveillance.The structure and maintenance model of MedDRA can facilitate its use.Since its inception as a user-driven terminology,MedDRA has grown in volume and expanded in scope under the care of the Maintenance and Support Services Organization(MSSO)to meet the needs of users and of evolving regulatory reporting and to keep up with the advances of medicine.

关 键 词：监管活动医学词典 分析查询 术语集 

分 类 号：R95[医药卫生—药学]