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EU pharmaceutical reform: why the agreement matters for children with cancer
On December 11, 2025, the Council of the EU and the European Parliament reached political agreement on a major reform of pharmaceutical legislation. The package includes changes to the framework for medicines for children and rare diseases.
For paediatric oncology, the scientific question is fundamental: could a medicine developed for an adult cancer also help children with a different tumour because they share relevant biology?
At ITCC-P4, this question guides the selection of models, the design of preclinical studies and the interpretation of results. Together with our exclusive CRO partners, we help developers build evidence to assess the paediatric potential of their medicines.
The agreement marks a legislative milestone. Its practical implementation follows a separate timetable; EMA currently anticipates application of the new framework in 2028.
Read the Council announcement and the EMA implementation timeline.