ICH guideline
ICH E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2D |
|---|---|
| Title | Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 2003. This document provides a standardised procedure for post-approval safety data management and the guidance for gathering and reporting information. This Guideline is based on the content of ICH E2A Guideline, with consideration as to how the terms… |
| File | E2D Concept Paper |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E2D Concept Paper Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.