EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Ojemda (tovorafenib) to treat patients aged 6 months and older with paediatric low-grade glioma (a type of brain tumour). Ojemda can...
Enpr-EMA’s annual meeting is a unique opportunity for networks and other stakeholders of paediatric clinical trials, such as health care professionals, parents, carers, patient representatives as well as medicine developers and regulators, to learn about...
The 2025 annual meeting of the members of the European network of paediatric research at the EMA (Enpr-EMA) and its Coordinating Group focused on recent Enpr-EMA developments, collaboration with ACT EU, and future strategic priorities....
This was the fourteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addressed all areas of evidence generation along the medicine’s life-cycle and related to development support activities,...
The EMA recently updated its “Procedural advice on paediatric applications” document. This guidance document provides comprehensive guidance on the procedures for submitting and managing paediatric applications to ensure the safety and efficacy of medicinal products...
Enpr-EMA 2024 meeting: The annual meeting of the members of Coordinating Group and members of European network of paediatric research at the EMA (Enpr-EMA) 2024 brought together paediatric trial networks and other stakeholders of Enpr-EMA...
This was the thirteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of evidence generation along the medicine’s life-cycle and related to development support activities,...
The E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. It provides a framework for using extrapolation to support paediatric drug development. The framework describes the...
The ICH fully adopted the ICH E11A Guideline on Pediatric extrapolation to be read in conjunction with the ICH E11(R1) Guideline on clinical investigation of medicinal products in the pediatric population. The E11A Guideline provides...
Support and guidance documents (templates, forms, procedural advice) to help applicants for paediatric medicines to submit their applications have been recently updated. More information on the Paediatric medicines: applications and procedures on the EMA Website.
