Project Orbis
Source: gov.uk (2025-10-01)

Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.

1.Overview

The programme provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies.

Project Orbis is coordinated by the US Food and Drug Administration (FDA). Alongside MHRA, it involves the regulatory authorities of:
- Australia (Therapeutic Goods Administration (TGA))
- Canada (Health Canada)
- Singapore (Health Sciences Authority (HSA))
- Switzerland (Swissmedic)
- Brazil (Agência Nacional de Vigilância Sanitária (ANVISA))
- Israel (Ministry of Health)
Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Each country remains fully independent on their final regulatory decision.

2. Products eligible for Project Orbis

Applications submitted to the MHRA within a Project Orbis procedure must be new marketing authorisation applications (MAAs) or new indication applications (variations) for oncology products.

When the Windsor Framework (https://www.gov.uk/government/collections/mhra-windsor-framework) came into force 1 January 2025, authorisations granted through this programme were applicable UK-wide. Before that date authorisations were limited to Great Britain only because medicinal products containing new active substances for the treatment of cancer fall within the mandatory scope of the European Medicine Agency (EMA) centralised procedure that applies in Northern Ireland.

You can find out more from our UK-wide licensing guidance (https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines/uk-wide-licensing-for-human-medicines).

The FDA coordinates the selection of products that will be included. Initial enquiries that the MHRA receive will be referred to the FDA. Submissions do not require an Innovation Passport designation for inclusion in the Project Orbis programme, though applicants can also apply for the Innovation Passport within the Innovative Licensing and Access Pathway (ILAP) if they wish to.

You can find out more in our guidance about ILAP (https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap-for-medicines).

Submissions will need to meet the FDA’s clinical criteria for priority review.

If you want the MHRA to submit a product or new indication for the Project Orbis programme, email xxx@xxx.xx (mailto:xxx@xxx.xx) with a summary of the product explaining how you meet the eligibility criteria. The MHRA will arrange a meeting with you to discuss eligibility.

3. Types of submissions

There are three different types of submission depending on the timelines between the FDA and the MHRA.

Type A

Applications should be submitted concurrently or near-concurrently (within 30 days) to the FDA and the MHRA. These are termed Type A Orbis (Regular Orbis) and allow for maximal collaboration during the review phase and the possibility of concurrent action with the FDA.

Type B

Applications submitted with a greater than 30-day delay or a regulatory action greater than 3 months of the FDA action are termed Type B Orbis (Modified Orbis) and allow the possibility of concurrent review with FDA but no concurrent action.

Type C

If the FDA has already taken regulatory action, a Type C Orbis (Written Report Only Orbis) will allows the FDA to share their completed review documents with the MHRA but there is no concurrent review or action with the FDA.

Table 1: Project Orbis Types

[2] Dependent on Project Orbis Partner (POP) guidelines. Contact specific POP(s) regarding optimal timing for submission of Type C dossier.

[3] Regulatory action in other jurisdictions is unlikely to occur immediately after FDA action and will follow respective health authority timelines.

4. Inclusion of the MHRA in a Project Orbis Procedure

Once a product or new indication has been identified for inclusion in Project Orbis, FDA will contact the MHRA to request their interest in involvement. If the request is provisionally accepted by the MHRA, the parent US Company will be advised and should provide details of the local UK affiliate to the MHRA.

MHRA participation is contingent on agreement with the UK affiliate.

5. Fees

You will need to pay the relevant national authorisation fee for any applications made to Project Orbis.

Find out more about our fees (https://www.gov.uk/government/publications/mhra-fees).

6. Assessment process and expert advice

The multidisciplinary assessment teams will carry out the assessment of the application.

The assessment process will include consultation with the MHRA Expert Advisory Groups and the Commission on Human Medicines, as required.

7. Publication

The granting of a UK marketing authorisation or new indication through Project Orbis will lead to publication of a UK Public Assessment Report.

8. Overview of Orbis Project approvals

Table 2

Further details on the approval can be found on the Public Assessment Report (https://products.mhra.gov.uk/).

The page will be updated on each Orbis project approval.

9. Further information

For more information or any questions please email xxx@xxx.xx (mailto:xxx@xxx.xx).