MHRA guidance on the Project Orbis initiative

Last updated: 12 January 2024

See updates at the end of the post.

The UK MHRA has published guidance on the Project Orbis initiative. Please read this post in conjunction with the MHRA guidance.

What is Project Orbis initiative is and how is the MHRA involved in this regulatory procedure?
  • 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.
  • It is coordinated by the US Food and Drug Administration (FDA)
  • While the FDA serves as the primary coordinator for application selection and review, Project Orbis Partners (POPs) may propose products for inclusion in the scheme.
  • Each country remains fully independent on their final regulatory decision.
  • Applications submitted to the MHRA within a Project Orbis procedure are national (Great Britain only) marketing authorisation applications and variations.
Which regulatory agencies are Project Orbis Partners (POPs)?

In addition to the US FDA, Project Orbis partners (POPs) include the regulatory agencies of:

  • Australia – Therapeutic Goods Administration (TGA) –
  • Brazil – Agencia Nacional de Vigilancia Sanitaria (ANVISA)
  • Canada – Health Canada
  • Israel Ministry of Health – See link
  • Singapore – Health Sciences Authority (HSA)
  • Switzerland – Swissmedic
  • United Kingdom – Medicines & Healthcare Products Regulatory Agency (MHRA)

Source: FDA

From what date did the UK MHRA become involved in the initiative?

The MHRA has become a full participant in the initiative since 1 January 2021.

More about the Project Orbis procedure

Project Orbis 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 across the globe.

  • Clinical criteria for FDA selection of applications for Project Orbis include high-impact and clinically significant applications. Project Orbis applications are generally expected to meet the criteria for FDA priority review. Qualifying criteria for FDA priority review include:
    • that the drug is intended to treat a serious condition and
    • if approved, would provide a significant improvement in safety or effectiveness.
Which products are 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. 

Who coordinates the selection of products to be included in Project Orbis?

Selection of products to be included in Project Orbis is coordinated by the FDA. Initial enquiries received by the MHRA will be referred to the FDA.

Where in the UK are authorisations granted via Project Orbis applicable?

Authorisations will be applicable in Great Britain only as oncology medicinal products fall within the mandatory scope of the European Medicine Agency (EMA) centralised procedure that applies in Northern Ireland. 

Where should a request for a new product or new indication for inclusion in Project Orbis be submitted?

If a company wishes the MHRA to propose a product or new indication for inclusion in Project Orbis then a request should be submitted via the MHRA’s Project Orbis mailbox, Orbis-MHRA@mhra.gov.uk, with a summary of the product and details of eligibility criteria.

Do submissions require an Innovative Passport designation for inclusion in the Project Orbis Programme?

No, 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.  

The types of Project Orbis submissions

There are three types of Project Orbis submissions and these are dependent on the timelines between the FDA and Participating Orbis Partners (POP). the submission types are detailed below:

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

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 – Written Report only Orbis

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 MHRA but there is no concurrent review or action with FDA.

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 MHRA.  
  • MHRA participation is contingent on agreement with the UK affiliate
What are the fees for Project Orbis?

You will need to pay the relevant national authorisation fee for any applications made to Project Orbis. Further information is available here.

What is the assessment process and who is consulted for 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.

Publication of a Great Britain-Public Assessment Report

Grant of a Great Britain marketing authorisation or new indication through Project Orbis will lead to publication of a Great Britain-Public Assessment Report. Public Assessment Reports can be accessed here,

Overview of Project Orbis Approvals

The MHRA has added a very useful section entitled Overview of Project Orbis Approvals to its webpage on Project Orbis. The section provides brief details about the following:

  • Product
  • Project type i.e. Intial marketing authorisation appplication or variation to add a new therapeutic indication
  • New indication – This field provides further information on a indication applied for
  • Grant date

The page will be updated following each Project Orbis approval.

Who can you contact for queries?

For any queries please contact the MHRA via email at Orbis-MHRA@mhra.gov.uk

Source: MHRA

Updates
DateUpdate
12 Jan 20241) Added new section Do submissions require an Innovative Passport designation for inclusion in the Project Orbis Programme? in line with the MHRA recently updating its guidance in relation to Project Orbis and ILAP to confirm that there is no longer a requirement to obtain an Innovation Passport as part of the Project Orbis programme.

2) Entire post revamped substantially to improve readability.
18 Mar 2022Heading of section Which regulatory authorities are involved in Project Orbis? updated to Which regulatory agencies are Project Orbis Partners? and content of the section updated to include Israel.
7 Mar 2022New section added entitled Overview of Project Orbis Approvals.