Module232025

5/7/2025

Overview of US and EU Paediatric Drug Development Laws • In general, obligations and incentives are similar but not identical . Main differences include exemptions, timelines, and processes for evaluation and exclusivity. • US and EU regulatory agencies require an assessment of product development in all paediatric populations in order to support certain types of marketing applications, unless a deferral or waiver is granted. • Rewards include development support and extension of exclusivity

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Children are not small adults ……. and they grow!

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