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
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5 (PDF/181.92 KB)Adopted
First published: 30/11/2003
Last updated: 30/11/2003
Legal effective date: 01/05/2004