On the 8th of December the FDA published an article promoting the Project Orbis initiative. In the article: Project Orbis: Strengthening International Collaboration for Oncology Product Reviews, Faster Patient Access to Innovative Therapies you can read more about Project Orbis’ first year, the involved regulatory authorities and the most common oncology indications represented in the submissions.

Project Orbis is an initiative that the US Food and Drug Administration (FDA) Oncology Centre of Excellence (OCE) launched in 2019 and provides a framework for concurrent submission and regulatory review of oncology products. 

Faster access to high-impact interventions

The scope of Project Orbis is to review oncology applications in parallel so that high-impact medical products can be made available earlier to patients outside the USA. Six regulatory authorities have agreed to participate in Project Orbis and while FDA serves as the primary coordinator each participating country remains fully independent on their final local regulatory decision.

To be accepted into the program a company generally is expected to meet the criteria of an FDA Priority Review designation with a medical product that would provide; ‘significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications’.

The first regulatory action under Project Orbis resulted in simultaneous approval decisions in three coordinated countries in 2019 and during the first year, 38 out of 60 oncology marketing applications were approved.

To learn more about Project Orbis and NDA’s experience supporting clients through this initiative read Project Orbis: How Trans-Jurisdiction Review Is Accelerating Global Product Launches or contact us at asktheexperts@ndareg.com

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