E11 - E11A Clinical Trials in Pediatric Population

E11(R1) Addendum: Clinical investigation of Medicinal Products in the Pediatric Population

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, regulatory requirements for pediatric study plans, and infrastructures for undertaking complex trials in pediatric patient populations has been considerably advanced in the last decade, without a parallel development of harmonised guidance in these areas.

This Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development.

Date of Step 4: 18 August 2017

Status: Step 5

Other Document (Click the links below for complete guidelines)

E11(R1) Final Addendum

Endorsed Documents (Click the links below for complete guidelines)

E11(R1) Concept Paper

WG Presentations / Trainings (Click the links below for complete guidelines)

E11(R1) Step 4 Presentation

E11A EWG Pediatric Extrapolation

This topic was endorsed by the ICH Assembly in June 2017. This new ICH Guideline is proposed for harmonisation of methodologies and strategies to incorporate paediatric extrapolation into overall drug development plans and therefore improve the speed of access to new drugs for paediatric patients while limiting the number of children required for enrolment in clinical trials.

The future E11A Guideline would address and align terminology related to paediatric extrapolation; provide information on various approaches that can be utilized to support the use of paediatric extrapolation; discuss a systematic approach to use of paediatric extrapolation; and provide information on study designs and statistical analysis methods used when incorporating paediatric extrapolation into a paediatric drug development plan.

Date of Step 2b: 4 April 2022

Status: Step 3

Guidelines (Click the links below for complete guidelines)

E11A Draft Guidelines

Endorsed Documents (Click the links below for complete guidelines)

E11A Concept Paper

E11A Business Plan

E11A Work Plan

WG Presentations/Training (Click the links below for complete guidelines)

E11A Step 2 Presentation

*These Guidelines Belongs to ICH website.