ICH guideline
ICH E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E1 |
|---|---|
| Title | The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH harmonised Guideline was finalised under Step 4 in October 1994. This document gives recommendations on the numbers of patients and duration of exposure for the safety evaluation of drugs intended for the long-term treatment of non-life-threatening conditions. |
| File | E1 Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- E1 Guideline Files published by ICH
- None 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.