# Project Orbis

Source: https://onco.cc/terms/project-orbis/  
OnCo record `project-orbis` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Project Orbis is a scheme where the FDA and partner regulators (Australia, Canada, UK, Switzerland, Singapore, Brazil, Israel) review a cancer drug at the same time.

## Summary

Project Orbis is a scheme under which the FDA and partner regulators in Australia, Canada, the UK, Switzerland, Singapore, Brazil and Israel review a cancer drug application at the same time. It began in 2019, and concurrent submission and review has shortened the gap between US approval and approval in partner countries from years to months for many oncology drugs. It is not a joint decision: each regulator reaches its own verdict independently. The term is referenced by the related terms BLA / NDA / MAA (marketing applications) and PDUFA dates and Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), and it appears in the global access and affordability roadmap and the trial modernisation roadmap as one of the mechanisms that move approvals across borders.

## Fields

- Kind: Term
- Last checked: 2026-09-08

## Sources

- FDA Project Orbis: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

## Connected records

- people: [R. Angelo de Claro](https://onco.cc/people/r-angelo-de-claro/)
- terms: [BLA / NDA / MAA (marketing applications) and PDUFA dates](https://onco.cc/terms/bla-nda/), [ICH good clinical practice (E6)](https://onco.cc/terms/ich-gcp/), [ILAP (Innovative Licensing and Access Pathway)](https://onco.cc/terms/ilap/), [Medicines and Medical Devices Act 2021](https://onco.cc/terms/medicines-medical-devices-act-2021/), [Regulation (EC) No 726/2004: the EU centralised procedure](https://onco.cc/terms/eu-regulation-726-2004/), [Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA)](https://onco.cc/terms/regulatory-agencies/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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