ICH guideline
ICH E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E5(R1) |
|---|---|
| Title | Ethnic Factors in the Acceptability of Foreign Clinical Data |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in February 1998. This document addresses the intrinsic characteristics of the drug recipient and extrinsic characteristics associated with environment and culture that could affect the results of clinical studies carried out in regions, and describes the concept… |
| File | E5(R1) Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E5(R1) 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.