Spring Intro 2023

30/03/2023

ORBIS

• Countries: US, Australia, Brazil, Canada, Israel, Singapore, Switzerland and GB

• Scope: FDA Oncology Center of Excellence (OCE) initiative, provides a framework for concurrent submission and review of oncology products among international partners. It is limited to oncology products for now. • From June 2019 (inception of program) to June 2020: • 60 oncology marketing applications (original drugs and new indications) • 38 approvals across the Project Orbis countries involved at the time (USA, Australia, Brazil, Canada, Singapore, Switzerland)

Project Orbis: Global Collaborative Review Program | Clinical Cancer Research (aacrjournals.org)

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How ? Key regions – China and Japan

Key points to remember in China and Japan • Importance of early engagement with the Agencies to build relationships and set in motion the development plan • Importance of clinical data in Chinese/Japanese patients • PK data in Chinese and Japanese patients • Include patients as part of the global program (ex-China ex-Japan) • China and Japan specific/Asia-specific studies • Ethnosensitivity (understanding the disease and pharmacokinetics)

• Significant cultural differences • Challenges working with local affiliate and distributors

The Organisation for Professionals in Regulatory Affairs

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