The Medical Dictionary for Regulatory Activities (MedDRA)
The Medical Dictionary for Regulatory Activities (MedDRA)
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DOI：
10.2165/00002018-199920020-00002
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发表时间：
1999-02-01
期刊：
影响因子：
4.2
通讯作者：
Wood, S
中科院分区：
文献类型：
--
作者：
Brown, EG;Wood, L;Wood, S
人用药品注册技术要求国际协调会议已就《国际医学用语词典》（MedDRA）第2.0版的结构和内容达成一致，该词典将于1999年初发布。该医学术语预期用于药品监管过程的上市前和上市后阶段，涵盖诊断、症状和体征、药物不良反应和治疗适应症，调查的名称和定性结果、手术和医疗程序以及病史/社会史。它可用于记录临床试验中的不良事件和病史，用于分析和制表这些试验的数据，用于向政府监管机构快速提交安全性数据，以及用于构建上市许可申请的标准产品信息和文件。药品获得许可后，可用于药物警戒，并有望成为国际电子监管通信的首选术语，MedDRA是一个5级多轴分层术语：术语可能存在于1个以上的垂直轴上，为数据录入提供了术语的特异性和数据检索的灵活性。MedDRA中的术语来自多个来源，包括WHO不良反应术语（WHO-ART）、不良反应术语词库编码符号（COSTART）、国际疾病分类（ICD）9和ICD 9-CM。它将由维护支持服务组织（MSSO）维护、进一步开发和分发。预计使用MedDRA将提高数据库中采集数据的质量，通过提供临床相关术语分组支持有效分析，并促进数据的电子通信，尽管作为一种新工具，用户需要投入时间来获得使用方面的专业知识。
The International Conference on Harmonisation has agreed upon the structure and content of the Medical Dictionary for Regulatory Activities (MedDRA) version 2.0 which should become available in the early part of 1999.This medical terminology is intended for use in the pre- and postmarketing phases of the medicines regulatory process, covering diagnoses, symptoms and signs, adverse drug reactions and therapeutic indications, the names and qualitative results of investigations, surgical and medical procedures, and medical/social history. It can be used for recording adverse events and medical history in clinical trials, in the analysis and tabulations of data from these trials and in the expedited submission of safety data to government regulatory authorities, as well as in constructing standard product information and documentation for applications for marketing authorisation. After licensing of a medicine, it may be used in pharmacovigilance and is expected to be the preferred terminology for international electronic regulatory communication.MedDRA is a hierarchical terminology with 5 levels and is multiaxial: terms may exist in more than I vertical axis, providing specificity of terms for data entry and flexibility in data retrieval. Terms in MedDRA were derived From several sources including the WHO's adverse reaction terminology (WHO-ART), Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART), International Classification of Diseases (ICD) 9 and ICD9-CM. It will be maintained, further developed and distributed by a Maintenance Support Services Organisation (MSSO).It is anticipated that using MedDRA will improve the quality of data captured on databases, support effective analysis by providing clinically relevant groupings of terms and facilitate electronic communication of data, although as a new tool, users will need to invest time in gaining expertise in its use.