Pediatric Cluster Terms of Reference - Initial Draft June 2007 - Last Updated June 2026

Oct 22, 2026

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Pediatric Cluster Terms of Reference define a confidential regulatory forum for coordinating pediatric medicinal product development across major agencies in the EU, US, Canada, Japan, Switzerland, and Australia. The document outlines shared ethical and scientific responsibilities for protecting children’s rights, safety, well-being, and dignity in research. It specifies objectives including exchange of pediatric development information, alignment with pediatric legislation through plans such as PIPs and PSPs, resolution of scientific divergences, and discussion of post-marketing pediatric requirements, risk management, and long-term safety monitoring.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

I. Introduction

II. Objectives

III. Scope

IV. Membership

Pediatric Cluster Terms of Reference Initial Draft June 2007; Last Updated June 2026 I. Introduction This document has been developed and agreed upon in the framework of the Confidentiality Commitments between the following regulatory agencies in the context of regulatory cooperation and transparency: the European Medicines Agency (EMA) of the European Union (EU), the United States (US) Food and Drug Administration (FDA), Health Canada, the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland, and the Therapeutic Goods Administration (TGA) of Australia. These regulatory agencies have created a confidential forum for discussion of scientific and ethical issues related to pediatric medicinal product development. This is known as the Pediatric Cluster. The International Council for Harmonisation E11 Clinical Investigation of Medicinal Products in the Pediatric Population (ICH E11) states that “Pediatric patients should be given medicines that have been appropriately evaluated for their use in those populations. Safe and effective pharmacotherapy in pediatric patients requires the timely development of information on the proper use of medicinal products in pediatric patients of various ages. Obtaining knowledge of the effects of medicinal products in pediatric patients is an important goal. However, this should be done without compromising the well-being of pediatric patients participating in clinical studies. This responsibility is shared by companies, regulatory authorities, health professionals, and society as a whole.” It is the responsibility of the regulatory agencies that are implementing or overseeing the programs for product development in pediatrics to ensure that the rights, safety, well-being, and dignity of children participating in research are protected. As such, children should be included in clinical trials only when it is scientifically and ethically justified. In the context of the Confidentiality Commitments between the regulatory member agencies of the Pediatric Cluster and the pediatric legislations and regulations in their respective countries, the engaged parties have taken a further step in agreeing on principles for interactions in relation to pediatric medicinal product matters. II. Objectives Commitment to provide a central forum for discussion of pediatric product development activities. Specifically: • To facilitate the regular exchange of information related to scientific and ethical issues and other information on pediatric product development programs that have been submitted to regulatory member agencies in Australia, Canada, the EU, Japan, Switzerland, and the US. This includes development programs submitted in response to pediatric legislations and regulations such as Pediatric Investigation Plans (PIPs) [EMA], Pediatric Study Plans (PSPs) [FDA], and Proposed Pediatric Study Requests (PPSRs)[FDA] to avoid exposing children to unnecessary or duplicative trials. • To encourage global pediatric product development that is compatible with the pediatric legislations and regulations within Australia, Canada, the EU, Japan, Switzerland, and the US. • To understand the scientific rationale when divergences in opinions exist between regulatory member agencies. • To discuss post-marketing pediatric requirements and issues including risk management and plans for long-term pediatric safety monitoring. • To discuss general topics of regulatory and scientific interest to the regulatory member agencies. • To inform the participants of planned scientific meetings or workshops related to pediatric matters with the possibility of attending the meetings. III. Scope Discuss issues pertaining to product classes and to product-specific development that arise during the regulatory life cycle (i.e., pre-and post-marketing) . Examples of issues for discussion include: • Conditions/indications for study •

FAQs

What is the Pediatric Cluster described in the document?

It is a confidential forum created by participating regulatory agencies to discuss scientific and ethical issues related to pediatric medicinal product development.

What are the main objectives of the Pediatric Cluster?

The document emphasizes regular information exchange on scientific and ethical issues, support for global pediatric development aligned with national regulations, understanding differing scientific rationales, and discussing post-marketing pediatric requirements including risk management and long-term safety monitoring.

What topics are within the scope for discussion?

The scope covers product-class and product-specific development issues across the regulatory life cycle, including study conditions and indications, deferrals, dosing, endpoints, ethics, extrapolation, formulations, modeling/simulation, nonclinical aspects, patient population, safety, study design, and waivers.

Oct 22, 2026

Uploaded by QWQ