Module232025

12/05/2025

Paediatric Plans: How to Facilitate the Process for a Global Aligned Review and Optimal Outcome

Optimal conditions for EMA & FDA collaboration on the paediatric plan • EMA–FDA parallel scientific advice procedure before finally drafting and submitting the PIP and iPSP • Include exactly the same information in the PIP and iPSP • Full transparency: Inform both agencies of all ongoing activities • Submit PIP and iPSP at about the same time, e.g., PIP first and then iPSP during clock-stop. This enables the FDA–EMA paediatric cluster discussion (occurs mainly during PIP clock-stop) • Propose as early as possible to the EMA coordinator for the PIP to be taken for discussion at FDA–EMA paediatric cluster meeting • Outcome of the cluster discussion included in the PIP summary report

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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Collaboration FDA and EMA

Joint EMA / FDA guidance on cancer medicines for use in children (April 2021) • Speed up the development and authorisation of cancer medicines for children, given the rarity of childhood cancers • Simultaneous submission, coordinated discussions, collaboration in the design and conduct of clinical trials Joint procedural information from EMA and FDA for medicine developers submitting a PIP and an iPSP for a COVID-19 vaccine or treatment (June 2020) • Make it easier for developers to submit paediatric development plans simultaneously • Help speed up the development and approval of COVID-19 treatments and vaccine

Joint

Joint

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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