Masterarbeit

Project Orbis - A Comprehensive Overview and its Global Impact on the Regulatory Industry, with Special Emphasis on Swissmedic

Gizem Yüce (2025)

Summary  

Language: English  

This study examines Project Orbis, launched in 2019 by the FDA’s Oncology Center of Excellence to accelerate global access to innovative oncology medicines by aligning parallel or near-parallel reviews among multiple regulators while preserving each agency’s final decision. It outlines the three Orbis pathways – Type A, Type B and Type C – and the criteria for inclusion. Swissmedic is used as a case example, selected for its mid-sized regulatory framework, to show how a national authority adapts existing procedures – waiving its initial clock-stop and syncing review milestones with Orbis schedules. 

A comparative look at Health Canada, Australia’s TGA, the UK’s MHRA and Brazil’s ANVISA shows that collaborative review under Orbis consistently leads to faster local authorizations. The thesis concludes with practical recommendations – clarifying eligibility rules, harmonizing dossier components and strengthening inter-agency communication – to further streamline multinational oncology regulation and speed patient access to innovative treatments.

Pages: 154, including references Annexes: 6, Pages: 55