The European Medicines Agency (EMA) has updated the terms of reference for the Pediatric Cluster, a confidential forum where six regulatory agencies discuss scientific and ethical issues related to pediatric medicinal product development. The document, last updated in June 2026 and published on 17 July 2026, formalises cooperation between EMA, the US Food and Drug Administration (FDA), Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Swissmedic, and Australia's Therapeutic Goods Administration (TGA). The cluster aims to avoid unnecessary or duplicative paediatric trials by facilitating the exchange of information on development programs such as Pediatric Investigation Plans (PIPs) and Pediatric Study Plans (PSPs).
The updated terms of reference, initially drafted in June 2007, reaffirm the agencies' commitment to the ICH E11 guideline, which states that paediatric patients should receive medicines appropriately evaluated for their use. The document outlines objectives including regular exchange of scientific and ethical information, encouraging globally compatible paediatric development, understanding divergences in regulatory opinions, discussing post-marketing safety monitoring, and informing participants of relevant scientific meetings. The scope covers product classes and product-specific development throughout the regulatory lifecycle, addressing issues such as conditions for study, deferrals, dosing, endpoints, ethics, extrapolation, formulations, modelling, nonclinical aspects, patient population, safety, study design, and waivers.
The cluster operates under confidentiality commitments between the agencies, ensuring that children's rights, safety, well-being, and dignity are protected in clinical research. By coordinating regulatory approaches, the forum seeks to reduce the burden on paediatric patients and sponsors while maintaining high scientific and ethical standards. The updated terms of reference reflect ongoing efforts to harmonise paediatric drug development across major regulatory jurisdictions.