ICH guideline
ICH E2F: Development Safety Update Report
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2F |
|---|---|
| Title | Development Safety Update Report |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in August 2010. The Development Safety Update Report (DSUR) proposed in this Guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The main… |
| File | E2F DSUR Examples Commercial Sponsors |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E2F DSUR Examples Commercial Sponsors 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.