Project Orbis: how cancer drugs are reviewed in several countries at once
A plain explanation for patients, families and doctors, checked against the regulator's own pages on 17 October 2026.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
Project Orbis is a program started by the FDA Oncology Center of Excellence in May 2019 so that cancer medicines can be submitted to and reviewed by several regulators at the same time. Its partners are the regulators of Australia, Brazil, Canada, Israel, Singapore, Switzerland and the United Kingdom. No Gulf regulator is listed, so Gulf patients still depend on local routes.
- Who runs it: FDA Oncology Center of Excellence.
- Started: May 2019.
- Partners: Australia, Brazil, Canada, Israel, Singapore, Switzerland, United Kingdom.
- Gulf: No Gulf regulator is a listed partner.
What Project Orbis does
The FDA Oncology Center of Excellence initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners. FDA, together with Australia's Therapeutic Goods Administration and Health Canada, took part in the first collaborative review; other countries have since joined as Project Orbis Partners.[1]
Concurrent review means a cancer medicine can be approved in partner countries close to the time it is approved in the US, instead of years later.
Which regulators take part
- Australia: Therapeutic Goods Administration (TGA).[1]
- Brazil: National Health Surveillance Agency (ANVISA).[1]
- Canada: Health Canada.[1]
- Israel: Ministry of Health Pharmaceutical Administration.[1]
- Singapore: Health Sciences Authority (HSA).[1]
- Switzerland: Swissmedic.[1]
- United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA).[1]
This list is from FDA's Project Orbis page as checked on 17 October 2026.
What it means for cancer patients in the Gulf
Because no Gulf regulator is a listed Orbis partner, a new US cancer approval does not automatically trigger a Gulf review. Registration depends on the manufacturer applying locally.
Why this matters in the Gulf: Saudi Arabia's SFDA runs reliance pathways that build on decisions by other regulators. Its performance target is 30 working days for the verification pathway, which needs approval and marketing by both the US FDA and the EMA, and 60 working days for the abridged pathway, which needs one of them. The manufacturer still has to apply; nothing happens automatically.[2]
Until a medicine is registered locally, a patient in the Gulf usually reaches an FDA-approved medicine through a hospital request to the national regulator, such as the SFDA Special Access Program in Saudi Arabia or the procedure in NHRA Circular 41 of 2020 in Bahrain.[3, 4]
For a cancer medicine approved in the US but not yet registered in your country, see our guide to cross-border cancer treatment and the country guides for Australia and Singapore, two Orbis partners.
How Project Orbis relates to FDA's expedited programs
Many cancer medicines reviewed through Project Orbis also move through FDA's expedited programs. Priority review sets FDA's goal at 6 months for action on the application, compared with 10 months for standard review, and accelerated approval allows approval on a surrogate endpoint such as response rate with confirmatory trials to follow.[5, 6]
Questions to ask the treating specialist
- Is the cancer medicine approved by the US FDA, and for which tumour type and biomarker?
- Is it registered in our country, or in a partner country such as the UK or Singapore?
- If not registered here, will the hospital request it for the named patient?
- Does the label need a companion diagnostic test, and has it been done?
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us whether a medicine can reach your patient
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
What is Project Orbis?
An FDA Oncology Center of Excellence program, started in May 2019, for concurrent submission and review of cancer medicines by FDA and partner regulators.
Which countries are in Project Orbis?
FDA lists the regulators of Australia, Brazil, Canada, Israel, Singapore, Switzerland and the United Kingdom as partners.
Is Saudi Arabia or the UAE part of Project Orbis?
Neither is on FDA's partner list as checked on 17 October 2026. Gulf access depends on local registration or a special access request.
Does Project Orbis make a cancer drug available sooner in my country?
Only in partner countries, and only if the manufacturer submits there. Elsewhere, the usual local routes apply.
Sources for these answers: [1, 2]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- US FDA Oncology Center of Excellence: Project Orbis (accessed 17 October 2026)
- SFDA: Verification and Abridged Pathways guidance, version 3.0 (October 2025) (accessed 17 October 2026)
- SFDA: Special Access Program (SAP) guidance, version 1.0 (accessed 17 October 2026)
- NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines (accessed 17 October 2026)
- US FDA: Priority Review (information for patients) (accessed 17 October 2026)
- US FDA: Accelerated Approval Program (accessed 17 October 2026)
Related
- FDA accelerated approval
- Cross-border cancer treatment guide
- All access pathways
- US expanded access (compassionate use)
- Named-patient access, explained
- Answers to common access questions
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.