Recommended for Adoption at Step 4 of the ICH Process on 20 July 2000 by the ICH Steering Committee

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.

Clinical investigation of medicinal products in the pediatric population

ICH Harmonised Tripartite Guideline

Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 19 July 2000, this guideline is recommended for adoption to the three regulatory parties to ICH

Clinical investigation of medicinal products in the pediatric population

Introduction

Objectives of the guidance

number of medicinal products currently labeled for pediatric use is limited. It is the goal of this guidance to encourage and facilitate timely pediatric medicinal product development internationally. The guidance provides an outline of critical issues in pediatric drug development and approaches to the safe, efficient, and ethical study of medicinal products in the pediatric population.

Background

ICH documents with relevant information impacting on pediatric studies include:

1. E2: Clinical Safety Data Management

2. E3: Structure and Content of Clinical Study Reports

3. E4: Dose-Response Information to Support Drug Registration

4. E5: Ethnic Factors in the Acceptability of Foreign Clinical Data

5. E6: Good Clinical Practice: Consolidated Guideline

6. E8: General Considerations for Clinical Trials

7. E9: Statistical Principles for Clinical Trials

8. E10: Choice of Control Group in Clinical Trials

9. M3: Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

10. Q1: Stability Testing

11. Q2: Validation of Analytical Procedures

12. Q3: Impurity Testing