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Beyond the adult indication: the EU reform’s mechanism-based approach
On March 6, 2026, the Council made the provisional pharmaceutical reform texts publicly available.
Article 75 of the regulation compromise would restrict a waiver based on a disease occurring only in adults if scientific evidence shows that the medicine’s mechanism is relevant to another paediatric disease within the same therapeutic area. A related qualification applies to the waiver ground concerning lack of significant therapeutic benefit.
For developers, this reinforces the importance of examining paediatric biology beyond the original adult indication. Molecular information can identify hypotheses; appropriate preclinical studies can then test the activity of the specific medicine in selected models.
ITCC-P4 supports this translation from scientific question to experimental evidence, working with paediatric oncology experts and our three exclusive CRO partners for studies using the ITCC-P4 PDX model portfolio.
These are provisions of the published compromise, not a statement that they are already applicable.