The EU Paediatric Medicines Regulation Print
The EU Paediatric Medicines Regulation came into force on 26th January 2007, aiming to provide better medicines for children. This Regulation is based on rewards, incentives and obligations for pharmaceutical companies; its intention was to accelerate the development of drugs for paediatric diseases, such as malignancies, with no expected direct return on investment for pharmaceutical companies. Warmly welcomed by the paediatric community, the Regulation was expected to facilitate access to anticancer drugs, which are in development in adults and to significantly increase the number of those drugs in clinical development for children and adolescents in Europe. However, the number of new oncology drugs in paediatric development remains low in Europe. There is still a 10-fold difference between Europe and the US in the number of new anticancer drugs available for clinical research.

The European Commission recently consulted stakeholders on whether the Regulation is delivering, which will feed into its ‘Five Year Report’ to the European Parliament and Council. View the Consultation.

SIOP Europe and other relevant stakeholders have responded to the Public Consultation. View our response.

SIOPE is the Work Package Leader for 'Dissemination' of the EU-funded, FP7 network of excellence, ENCCA - the European Network for Cancer research in Children and Adolescents –

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