Paediatric medicines

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European Network of Paediatric Research at the European Medicines Agency

Published by IRDiRC

Early Access SupportEuropean Network of Paediatric ResearchOrphan DrugPaediatric MedicineRegulatory AffairsResearch and Drug Development

The European Network of Paediatric Research at the European Medicines Agency (Enpr- EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children. Enpr-EMA enables networking and collaboration with members from within and outside the European Union (EU), including academia and the pharmaceutical industry

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Paediatric Regulation

Published by EU

Early Access SupportEMA Paediatric RegulationOfficial JournalPaediatric MedicinePaediatric RegulationRegulatory Affairs

The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately and improving the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults.

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