E11A – Paediatric Extrapolation

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E11A – Paediatric Extrapolation

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 E11A Guideline provides a framework for using extrapolation to support paediatric drug development. The framework describes an iterative process for understanding the existing information available, the gaps in information needed to inform development, and ways to generate additional information when required and recommends approaches to assessing factors that influence the determination of similarity of disease, drug pharmacology, and response to treatment between a reference and paediatric target population. In addition, it discusses how the characteristics of the disease, drug pharmacology and response to treatment may influence this determination.

This guideline is intended to complement and expand on ICH E11(R1) to provide a more comprehensive framework for using paediatric extrapolation in optimising paediatric drug development. ICH E11 (2000) and ICH E11(R1) (2017) should be considered companion guidelines which provide guidance on the approach to safe, efficient, and ethical paediatric medicines development.

The ICH Harmonised Guideline was finalised under Step 4 in July 1997. This document covers the preclinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.

An addendum was proposed to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 Guideline: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. The Harmonised addendum provides further complementary guidance to the S6 Guideline and helps to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.

The addendum reached Step 4 of the harmonisation process in June 2011 and was integrated as part II in the core Guideline that was then renamed S6(R1).

Guideline

Endorsed Documents

WG Presentations/ Training

E11A Step 4 Presentation

E11A Module 1

Annexes

Guideline implementation

ANMAT, Argentina

Not yet implemented;

ANVISA, Brazil

Not yet implemented;

COFEPRIS, Mexico

Not yet implemented;

EC, Europe

Implemented; Date: 25 January 2025; Reference: EMA/CHMP/ICH/205218/2022

EDA, Egypt

In the process of implementation;

FDA, United States

Implemented; Date: 30 December 2024; Reference: 89 FR 106515

HSA, Singapore

Not yet implemented;

Health Canada, Canada

Implemented; Date: 15 October 2025; Reference: File #: 25-105890-674

JFDA, Jordan

Not yet implemented;

MFDS, Republic of Korea

Not yet implemented;

MHLW/PMDA, Japan

Implemented; Date: 7 July 2026;

MHRA, UK

Not yet implemented;

NAFDAC, Nigeria

Not yet implemented;

NMPA, China

Implemented; Date: 18 November 2024; Reference: NMPA, China Announcement No. 139 (2024)

SAHPRA, South Africa

In the process of implementation;

SFDA, Saudi Arabia

In the process of implementation;

Swissmedic, Switzerland

Implemented; Date: 21 August 2024; Reference: ICH Guidelines apply in Switzerland automatically upon reaching Step 4: Swissmedic Journal 05/2006, p. 504

TFDA, Chinese Taipei

Implemented; Date: 19 June 2025; Reference: Guidance for Pediatric Pharmacokinetic Studies

TITCK, Türkiye

Not yet implemented;