Brown E G, Wood L, Wood S
Medicines Control Agency, London, England.
Drug Saf. 1999 Feb;20(2):109-17. doi: 10.2165/00002018-199920020-00002.
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 1 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.
国际协调会议已就《药品监管活动医学词典》（MedDRA）2.0版的结构和内容达成一致，该版本预计于1999年初发布。此医学术语旨在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、检查的名称和定性结果、手术和医疗程序以及医学/社会病史。它可用于在临床试验中记录不良事件和病史，用于这些试验数据的分析和制表，以及向政府监管当局快速提交安全数据，还可用于构建标准产品信息和上市许可申请文件。药品获批上市后，它可用于药物警戒，预计将成为国际电子监管通信的首选术语。MedDRA是一个具有5个层级的层级术语，并且是多轴的：术语可能存在于多个垂直轴上，为数据录入提供术语的特异性，并在数据检索方面提供灵活性。MedDRA中的术语来源于多个来源，包括世界卫生组织的不良反应术语（WHO-ART）、不良反应术语词库编码符号（COSTART）、国际疾病分类（ICD）9和ICD9-CM。它将由一个维护支持服务组织（MSSO）进行维护、进一步开发和分发。预计使用MedDRA将提高数据库中捕获的数据质量，通过提供临床相关的术语分组来支持有效的分析，并促进数据的电子通信，不过作为一种新工具，用户需要投入时间来获取使用它的专业知识。
