Project Orbis

AI Summary

Project Orbis is an international collaborative framework coordinated by the US FDA, involving the UK Medicines and Healthcare products Regulatory Agency (MHRA) and other global partners. This initiative aims to accelerate patient access to innovative oncology treatments. Under the Windsor Framework, effective January 2025, drug authorisations granted through this program apply across the entire United Kingdom. The program focuses on new oncology marketing authorisations and variations that meet priority review criteria. While the document does not list violations, it establishes the regulatory framework to address delays in global treatment availability. Various companies, including AstraZeneca, Gilead, and Merck, have successfully utilized this pathway for products such as Tagrisso and Keytruda, with grant dates ranging from May 2021 to projected dates in 2026. Applicants must choose from three submission types (A, B, or C) based on their filing timelines relative to the FDA. To participate, manufacturers must email the MHRA to request an eligibility meeting, pay the required national fees, and undergo a multidisciplinary assessment. Approved applications culminate in the publication of a UK Public Assessment Report.