Module232025

12/05/2025

• Access Consortium • Aims to provide patients with timely ‘access’ to high quality, safe and effective therapeutic products • TGA, HC, HSA, Swissmedic, MHRA

• Project Orbis

• FDA coordinated • Novel products and line

extensions in oncology, offering meaningful improvement over existing therapy • Priority review timetable • Coordinated evaluation with FDA, TGA, HC, MHRA, Swissmedic, HSA, ANVISA, Israel MoH

The Organisation for Professionals in Regulatory Affairs

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Paediatric Cluster

• Participating Countries: EU, USA, Canada, Australia, Japan • a space for regulatory agencies to have high level discussions on key scientific issues of concern related to paediatric development plans • supported legally by confidentiality agreements, it provides regulators with the important opportunity to discuss the scientific underpinnings of the plans and seek approaches to address hurdles in trial design which would facilitate the implementation of global development plans • a potential outcome is to agree to summarise discussions on a development plan as part of a common commentary, enabling agencies to further inform the next procedural steps foreseen within the respective regulatory frameworks providing clarity on common and also more rare instances of divergent views.

The Organisation for Professionals in Regulatory Affairs

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