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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。
Provides data elements for manufacturers to report adverse events to a national regulatory authority. Determine what is necessary to report adverse events to the national authorities, at a minimum, including these data.