[关键词]
[摘要]
医学文献监测指在一定范围内,收集、评估并上报待监测活性物质的不良反应报告,以提高上报不良反应报告的效率与质量,是药品不良反应(adverse drug reaction,ADR)管理和报告的重要环节。欧洲药品管理局(EuropeanMedicines Agency,EMA)是最早开展医学文献监测的机构之一,现已建立了较规范的医学文献监测方案和较为成熟的评估体系。通过介绍分析EMA医学文献监测体系,并结合我国ADR监测现状与存在的问题,从制定监测技术指南与质量管理规范、推动不良反应信息公开等方面提出政策建议,为健全ADR监测体系提供参考。
[Key word]
[Abstract]
Medical literature monitoring (MLM) refers to screening, processing and reporting active substances that are monitored in a certain range to improve the efficiency and quality of ADR reports, which closely connect ADR management and reporting process. European Medicines Agency (EMA) is one of the first institutions to monitor the medical literature. After continuous exploration and reform, a standardized scheme and mature MLM evaluation system has been established. With the introduction and analysis of MLM system, combining with the current situation and existing problems of it in China, this paper puts forward policy suggestions in several aspects, such as formulating supporting technical guidelines to standardize monitoring details of each step, formulating MLM quality management standards to strengthen the supervising process, and promoting the disclosure of adverse reaction information to improve data sharing mechanism.
[中图分类号]
R951
[基金项目]
国家中医药管理局中医药行业科研专项(201507004);国家食品药品监督管理总局保健食品审评中心保健食品原料目录研究专项课题(ZBW-2017-BJSP-10)