Project Orbis provides a framework for concurrent submission and review of regulatory dossiers with member agencies in the project, and has the goal of providing faster patient access to innovative cancer therapies with a high unmet medical need across its participating countries. A sponsor’s decision to participate in Project Orbis is influenced by a number of factors including the complexity of the application, the potential for faster review timelines and resource availability, both internally and within participating authorities, which in turn have an impact on which countries and Orbis types are selected and ultimately whether a sponsor will be able to participate.

This article summarises AstraZeneca’s experiences to date with Project Orbis, including strategic considerations for participation, challenges and opportunities faced during the review, as well as considerations for the future direction of the programme.