1U.S. Food and Drug Administration, Division of Regulatory Operations for Oncologic Diseases, Silver Spring, MD, USA
10Brazilian National Health Surveillance Agency, Brasília, Brazil
11Pharmaceuticals and Medical Devices Agency, Office of New Drug V, Tokyo, Japan
12Pharmaceuticals and Medical Devices Agency, Division of Consultation, Kansai Branch, Osaka, Japan
13European Medicines Agency, Amsterdam, The Netherlands
14Therapeutic Goods Administration, Canberra, ACT, Australia
15The Medical Technology, Health Information, Innovation and Research Directorate, Ministry of Health, Jerusalem, Israel
16Health Canada, Government of Canada, Ottawa, Canada
17U.S. Food and Drug Administration, Office of Oncologic Diseases, Silver Spring, MD, USA
2U.S. Food and Drug Administration, Oncology Center for Excellence, Silver Spring, MD, USA
3U.S. Food and Drug Administration, Global Policy and Strategy, Silver Spring, MD, USA
4University of Rhode Island, College of Pharmacy, Kingston, RI, USA
5University of Florida, College of Pharmacy, Gainesville, FL, USA
6Chicago State University, College of Pharmacy, Chicago, IL, USA
7Health Sciences Authority, Singapore, Singapore
8Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland
9Medicines and Healthcare Products Regulatory Agency, London, United Kingdom
*Corresponding author
Online Published on 01 July, 2025.
The purpose of this paper is to provide a guideline for understanding and comparing the regulatory framework of Project Orbis Partners (POPs) and Project Orbis observers, with a focus on their approaches to drug approvals, rejections, and withdrawals. While each agency has its own regulatory framework and guidance, there are some similarities and differences between the language used to describe drug approvals, rejections, withdrawals, and the public availability of these decisions. Project Orbis is an international partnership of regulatory agency, led by the U.S. Food and Drug Administration (FDA), aimed at streamlining the submission and review processes to expedite the global availability of oncology medications for patients. Since its inception, Australia’s Therapeutic Goods Administration (TGA), Brazil’s National Health Surveillance Agency (ANVISA), Canada’s Health Canada (HC), Israel’s Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, Singapore’s Health Sciences Authority (HSA), Switzerland’s Swissmedic (SMC), and United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) have joined and become POPs. Other international agencies such as, the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are currently observing Project Orbis, as of late 2023. They are not full Project Orbis partners but work closely with the FDA to facilitate oncology drug approval through international collaboration.
An Index of the FDA and international regulators involved in Project Orbis looking at the similarities and differences between approval, rejection, and withdrawal characteristics of applications and public transparency of actions.
Global, Transparency, Approvals, Complete Response, Rejection, Withdrawal, Project Orbis Partners (POPs), AusPAR
