ICH guideline
ICH E11A EWG: Paediatric Extrapolation
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E11A EWG |
|---|---|
| Title | Paediatric Extrapolation |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2017. The ICH E11A Guideline reached Step 4 of the ICH process on 21 August 2024.The E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. The… |
| File | E11A Module 1 |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E11A Module 1 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.