Project Orbis Drug Registration 2025

Efforts to accelerate global regulatory processes are increasing as health authorities seek to collaborate and reduce redundant work. One such initiative is Project Orbis, an international collaboration established in 2019 by the FDA's Oncology Center of Excellence to facilitate the submission, review, and approval of oncology drugs. Project Orbis allows for concurrent submissions and collaborative reviews among participating partner countries, including Australia, Brazil, Canada, Israel, Singapore, Switzerland, the United Kingdom, and the United States. This framework has already resulted in numerous approvals, helping to deliver life-saving cancer therapies to patients more rapidly.

To be considered, a product must be an oncology drug, and the application must be a new drug application or a new indication application. The FDA is the primary coordinator, and while sponsors can propose an application for consideration, the final selection is at the FDA's discretion

Project Orbis offers a way for sponsors to accelerate oncology drug approvals through a collaborative review process. To understand the different types of submissions and the specific application requirements, read the full white paper.