Today we are focusing on the Project Orbis initiative, with a UK slant.


What is Project Orbis?
Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) involving several other participants. The programme has been set up to allow participating partners to review and approve applications for promising cancer treatments quickly and efficiently.


Which countries are involved in the Project?
It involves the regulatory authorities of:
  1. US (FDA)
  2. Australia (TGA)
  3. Canada (Health Canada)
  4. United Kingdom (MHRA)*
  5. Singapore (HSA)
  6. Switzerland (Swissmedic)
  7. Brazil (ANVISA)
*Since 1st January 2021.


Which products are eligible for Project Orbis?
New marketing authorisation applications (MAAs) and new indication applications (variations) for oncology products are eligible for Project Orbis.
Selection of products to be included in Project Orbis is coordinated by the FDA, and initial queries received by participating regulatory health authorities are referred to the FDA.
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:
  • the drug is intended to treat a serious condition
  • and if approved, would provide a significant improvement in safety or effectiveness.
Does the MHRA have any further criteria for product eligibility?
For the MHRA, Project Orbis submissions should also meet the qualifying criteria for the Innovation Passport within the Innovative Licensing and Access Pathway (ILAP). Inclusion in ILAP is a requirement for participation of the MHRA as a Participating Orbis Partner (POP).


How do I propose a product or new indication via the MHRA?
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 Project Orbis mailbox,, with a summary of the product and details of eligibility criteria.


What are the different types of Project Orbis submissions?
There are several types of Project Orbis submissions and these are dependent on the timelines between the FDA and Participating Orbis Partners (POP).


Type A – Regular Orbis
Applications should be submitted concurrently or within 30 days to FDA and the POPs. These are termed Type A 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 and allow the possibility of concurrent review with FDA but no concurrent action.


Type C – Written Report Only Orbis
Finally, where FDA has already taken regulatory action, there is a Type C Orbis which allows FDA to share their completed review documents with the POP but there is no concurrent review or action with FDA.


What is the process for including 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 POPs 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 and inclusion of the product/new indication in ILAP.


What if the product or new indication is already accepted for ILAP?
For products and new indications already accepted in ILAP, a meeting will be arranged to discuss practical arrangements for submission, including the requirements for orphan productspaediatric investigation plans (PIPs) and pharmacovigilance including risk management plans (RMPs).


What if the product or new indication is not already accepted for ILAP?
If the product or new indication is not already accepted for ILAP, the MHRA will arrange an Innovation Passport meeting as soon as possible after the request for inclusion in Project Orbis to confirm eligibility based on a review of the top-level clinical data. The meeting will also address practical arrangements for the submission.


How will the application be assessed?
The multidisciplinary assessment teams will carry out the assessment of the application collaborating with Vigilance and Risk Management of Medicines assessors for evaluation of the RMP. The assessment process will include consultation with the MHRA Expert Advisory Groups (EAGs) and the Commission on Human Medicines (CHM), as required.


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