Module232025

12/05/2025

Paediatric Cluster – respective responsibilities

• Regulators • Report to sponsors with action items agreed on the call (eg PIP summary report or FDA follow up email) • Provide sponsors with the agreed common commentary in a timely manner or feedback in case not

• Industry • Transparency about and coordination of respective submissions, facilitating the assessment of the respective development plans by regulators and thus also discussions during the paediatric cluster

The Organisation for Professionals in Regulatory Affairs

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Common Commentary - oncology

• Common commentary document on paediatric oncology drug development (2021) • Call for simultaneous submission of iPSPs and PIPs in 2020 • the differences in regulations related to timeline are not considered posing a barrier in that regard • Detailed feedback on Regulator’s expectations regarding the administrative and product information, but also the proposed paediatric plan and the corresponding timelines • Key areas and issues commonly requested by regulatory agencies

The Organisation for Professionals in Regulatory Affairs

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