From 01 January 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) will join the US Food and Drug Administration’s (FDA) Project Orbis.
Project Orbis is an initiative of the FDA Oncology Centre of Excellence (OCE), and provides a framework for concurrent submission and review of oncology products among international partners from Australia, Brazil, Canada, Singapore, Switzerland, UK and USA. The primary aim of Orbis is to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies across the globe.
The MHRA, who will become a full participant in the scheme at the end of the Brexit Transition period, have released guidance on their involvement in this regulatory pathway. The guidance details the products eligible for Project Orbis, as well as the types of submissions applicable through this pathway.
Once a product or new indication has been identified for inclusion in Project Orbis, FDA will contact its international partners to request their involvement. If the request is provisionally accepted by the MHRA, the product’s 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 and inclusion of the product/new indication in Innovative Licensing and Access Pathway (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 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, including the requirements for orphan products, paediatric investigation plans (PIPs) and pharmacovigilance. Requests for meetings will need to be sent to the Project Orbis mailbox, Orbis-MHRA@mhra.gov.uk. Following receipt of the request, the MHRA will arrange a mutually acceptable date for the meeting. For products and new indications already accepted in ILAP, a meeting will be arranged to discuss practical arrangements for submission.
The guidance also outlines procedures regarding Health Technology Assessment Agencies, fees and assessment processes.
For more information, click here.