ICH E2D Post-approval safety data management - Scientific guideline

Table of contents

This document aims to establish an internationally standardized procedure to improve the quality of post-approval safety information and to harmonise the way of gathering and reporting information. It provides guidance on definitions and standards for post-approval expedited reporting, as well as good case management practices.

Keywords: Expedited reporting, post-approval drug safety, individual case safety reports, adverse event (AE), adverse drug reaction (ADR), spontaneous reports, solicited sources, lack of efficacy, overdose, pregnancy exposure, follow-up information, reporting time frames


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