CRED ERP 25

01/07/2025

Main pillars Paediatric Regulation

• An expert committee: the Paediatric Committee ( PDCO )

• An agreed (evolving) paediatric development: the Paediatric Investigation Plan ( PIP ) • A system of obligations and rewards (e.g. ‘patent’ extension, free scientific advise)

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Paediatric Investigation Plan (1/2)

⚫ Paediatric investigation plan (PIP) – a development plan aimed at ensuring that the necessary data are obtained to support the authorisation for children of new medicines or new indication, pharmaceutical form or route of administration

- Should be submitted around end of Phase I studies

- Outlines timing and measures to be undertaken

- Deferral or waiver possible, if applicable

- Modifications possible

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