Abstract
Project Orbis, launched by the US FDA in 2019, enables collaboration among international regulatory agencies on cancer drug reviews. We assessed the regulatory impact of Project Orbis in Canada by analyzing publicly available data on marketing authorization applications (MAAs). We analyzed US‐Canada submission and approval gaps, time to regulatory decision, tumor areas, and sponsor involvement. From September 20, 2019 to the end of 2025, Health Canada approved 97 Orbis and 161 non‐Orbis oncology MAAs. Orbis MAAs had a shorter median submission gap than non‐Orbis MAAs, as well as a shorter median approval gap. Median time to decision was shorter for Orbis MAAs than non‐Orbis MAAs and was related to accelerated or standard review pathways. The time to decision was consistent with Health Canada's performance standards, and notably, Orbis type A median time to decision was similar for standard and priority review MAAs. Health Canada has been a highly active Project Orbis partner. Further research is needed to determine whether Orbis accelerates the overall time from regulatory filing to patient access to treatment, inclusive of health technology assessment and reimbursement negotiation processes.