In January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) joined the FDA led program, Project Orbis. This month they have announced the first authorisation under the scheme.

Project Orbis is a program coordinated by the US Food and Drug Administration (FDA) in collaboration with Canada, Australia, Switzerland, Singapore, Brazil and the UK. The initiative offers a framework for concurrent submissions and collaboration reviews for promising cancer treatments.

The first product approved by the MHRA as part of Project Orbis, AstraZeneca's Tagrisso (osimertinib), is a previously licensed post-surgery treatment for patients with mid and later stage non-small cell lung cancer (NSCLC). The treatment scope of the drug has now been expanded under Project Orbis to include a new population of patients in early-stage disease offering a novel treatment option for these patients after their cancer has been surgically removed.

MHRA press release

The NDA team has supported several companies maneuver the fast paced challenges and possibilities faced when filing through Project Orbis.

Contact us to learn how we can support you and your team or download our recent webinar, Project Orbis: What you need to know presented by our Project Orbis lead consultant, Claudia Reichle.



Stay up to date

Contact us

Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

Let's Bring Medicines to the World