Definition
Project Orbis is an FDA initiative launched in 2019 enabling concurrent submission and review of oncology drugs with international regulatory partners. The program allows patients worldwide to access cancer treatments more quickly through coordinated approval processes.
How Project Orbis Works
FDA’s Oncology Center of Excellence leads collaborative review with partner agencies. Each agency maintains sovereignty over final decisions while sharing assessments and insights.
Participating Agencies
| Agency | Country |
|---|---|
| FDA | United States |
| TGA | Australia |
| Health Canada | Canada |
| HSA | Singapore |
| Swissmedic | Switzerland |
| MHRA | United Kingdom |
| ANVISA | Brazil |
Project Orbis Benefits
- Concurrent Review: Multiple agencies review simultaneously
- Shared Assessment: FDA shares review with partners
- Faster Global Access: Near-simultaneous approvals possible
- Reduced Duplication: Streamlined regulatory effort
- Knowledge Sharing: Agencies benefit from collaborative expertise
Why BD Teams Track Project Orbis
For business development professionals, Project Orbis enables global strategy:
- Deal Implication: Concurrent multi-market approval enhances product value and launch strategy
- Due Diligence Focus: Project Orbis participation indicates high-quality oncology assets
- Opportunity Signal: Global approval coordination may affect regional partnership strategies