制造商递交国家授权管理机构的最少数据

Minimum Data Set for ManufacturerReports to Competent Authority

提供了制造商向国家授权管理机构上报不良事件的数据要素。确定向国家授权管理机构报告不良事件所必需的内容,最少包括这些数据。

Data Elements for Reporting an Adverse Event from Manufacturer to Regulatory Authority.Define the necessary elements to be reported to a Regulatory Authority regarding an adverse event.These elements would be the minimum to be reported.