ICH guideline
ICH E17: General principles for planning and design of Multi-Regional Clinical Trials
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E17 |
|---|---|
| Title | General principles for planning and design of Multi-Regional Clinical Trials |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 2017. This Guideline provides guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT). Drug development has been globalised and MRCT for regulatory submission has widely been conducted in ICH regions and beyond… |
| File | E 17 Training Module 1 video |
| File type | Video |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- E 17 Training Module 1 video Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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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.