13 March 2026 - The EMA has released a concept paper proposing a future reflection paper on the development of non-clinical proof of concept studies to support novel oncology treatments for the paediatric population.

EMA said the aim of the reflection paper is to give a more structured regulatory framework for developing these studies. It is also meant to “provide recommendations that drive the generation and assessment of meaningful proof-of-concept data to support the development of medicinal products in paediatric oncology and to outline the challenges associated with evaluating such data.” 

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