ICH国际医学用语词典(MedDRA):药事管理的标准医学术语集

Internationally agreed medical terminology: Medical Dictionary for Regulatory Activities

ICH国际医学用语词典(MedDRA)在ICH主办下创建,是供政府药事管理部门与生物制药工业管理新药上市前后的临床研究各阶段的标准术语集。该术语集支持各种临床数据的编码、检索与分析,如不良事件、医学与社会史、适应症与临床检查。本文叙述了MedDRA的创建原因与历程等背景信息,MedDRA术语的分级结构,MedDRA的规则与习惯,MedDRA在数据编码与分析中的应用,以及ICH参加国/地区政府对MedDRA使用的行政要求。最后探讨了MedDRA在中国推广使用的前景。

The Medical Dictionary for Regulatory Activities （MedDRA） was developed under the auspices of International Conference on Harmonisation （ICH）. It is the standard terminology use by regulators and the biopharmaceutical industry through all phases of clinical development and in the post-marketing arena. The terminology supports the coding, retrieval, and analysis of a variety of clinical data, including adverse events, medical and social history, indications and investigations. This article provides the background information on how and why MedDRA was created. The MedDRA terminology hierarchy structure, MOdDRA rules and conventions, the applications of MedDRA in coding and data analysis, regulatory mandate status within the ICH regions, and the potential use of MedDRA in China are discussed.