> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ICH Pediatric Guideline at Step 4
- URL: https://www.fdaweb.com/ich-pediatric-guideline-at-step-4/
- Published: 2020-04-15T12:00:00.000Z
- Updated: 2026-09-14T16:11:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146569

The International Council for Harmonization (ICH) says its S11 guideline on nonclinical safety testing supporting the development of pediatric medicine reached Step 4 of the ICH process this month. ICH [says](https://ich.org/news/ich-s11-reaches-step-4-ich-process?ref=fdaweb.com) the [guideline](https://www.ich.org/page/safety-guidelines?ref=fdaweb.com#11-1) provides direction on the nonclinical safety studies important to support a pediatric development program. It reportedly recommends standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support pediatric clinical trials and also provides guidance on designing the studies.