ICH guideline
ICH E2D(R1): Post-Approval Safety Data: Definitions and Standards for Management and Reporting of…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2D(R1) |
|---|---|
| Title | Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2019. The ICH E2D(R1) Guideline reached Step 4 of the ICH process on 15 September 2025. The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management practices. The… |
| File | E2D(R1) Training Material |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E2D(R1) Training Material 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.