ICH guideline
ICH E11(R1): Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E11(R1) |
|---|---|
| Title | Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and Addendum |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | Since the adoption of the ICH E11 Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population in 2000, pediatric drug development has been enhanced by advancements in several areas of general adult drug development. Targeted scientific and technical issues relevant to pediatric populations… |
| File | E11(R1) Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E11(R1) Step 4 Presentation 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.