刍议药品生产企业如何报告个例药品不良反应

Discussion on How Drug Manufacturers Report Individual Case Adverse Drug Reactions

通过系统回顾我国法律法规、ICH与ISPE相关指导原则,分析了自发报告、源于有组织数据收集系统的报告、源于文献的报告、境外发生的严重报告、合同报告以及其他来源等6种不同来源药品不良反应/事件报告,对个例报告提出了最低报告要求、报告内容与时限,对源自有组织数据收集系统的报告、境外发生的严重报告提出了具体报告要求,在汇总报告中提出了如何分析个例报告的要求,以期为国内药品生产企业按要求报告药品不良反应/事件提供参考。

This paper systematically reviewed laws and regulations in our country, relevant guidelines of ICH and ISPE, analyzed six different sources of adverse drug reactions/ adverse events, such as spontaneous reports, sourced from organized data collection scheme,literature,abroad, contractual agreements and other sources, put forward the minimum data elements, contents and time frames of individual report,specific reporting requirements of those sourced from organized data collection scheme and abroad,and put emphasis on the requirements on how to analyze individual report in summary report. It＇s aimed to provide reference for manufacturers according to reporting requirements.