A framework for concurrent submission and review of oncology products
The FDA Oncology Center of Excellence (OCE) launched Project Orbis in May 2019 to establish a framework for the concurrent submission and review of oncology products among international regulatory partners.
International regulatory collaboration may provide cancer patients with earlier access to treatments in countries where regulatory submissions often face significant delays, regardless of whether the product has already received FDA approval. Pivotal oncology clinical trials are frequently conducted on a global scale, and these international studies are increasingly vital for evaluating the safety and efficacy of cancer drugs seeking U.S. approval. Future drug development efforts may benefit from greater uniformity in global treatment standards, which can facilitate the optimal design of these essential trials.
Since its inception, Project Orbis has received numerous oncology marketing applications and has resulted in the approval of many cancer therapies for patients worldwide. For further details, please consult the Project Orbis approval report.
R. Angelo de Claro is a hematology-oncology physician and currently serves as the Associate Director (Acting) for Global Clinical Sciences within the Oncology Center of Excellence. In this capacity, he directs OCE initiatives to advance global cancer drug development and regulatory science, including the oversight of Project Orbis. Dr. de Claro also serves as the Division Director for the Division of Hematologic Malignancies I in the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA.
Dianne Spillman is the Associate Director for Global Regulatory Outreach in the Oncology Center of Excellence. She earned a Bachelor of Science in Biology from Northeastern University in Boston, MA. Her government career spans three decades, with 27 years dedicated to FDA oncology offices and divisions. Dianne began her career in 1990 as a research assistant for the Veterinary Research Program at the National Institutes of Health. In 1993, she joined the FDA/CDER Division of Oncology and Pulmonary Drug Products as a project manager. From 2002 to 2005, she served as Special Assistant to Dr. Richard Pazdur, the former Director of the Division of Oncology Drug Products. Between late 2005 and early 2019, she acted as the Lead Project Manager for the Oncology Program in the Office of Hematology and Oncology Products. Currently, Dianne manages OCE interactions with international regulatory counterparts and played a key role in the first international collaborative review involving Australia, Canada, and the U.S. under Project Orbis.
Lauren Tesh Hotaki is a Senior Health Scientist at the OCE. She holds a Doctor of Pharmacy degree from The Philadelphia College of Pharmacy and maintains board certifications in Pharmacotherapy (2012) and Infectious Diseases from the Board of Pharmacy Specialties. Lauren has been in public service since high school, having interned at the Department of Veterans Affairs (VA) and worked as a pharmacy technician at the Washington, DC VA Medical Center during her pharmacy studies. Before joining the FDA, Lauren served as an Assistant Professor of Pharmacy Practice at the South College School of Pharmacy in Knoxville, TN, and completed two years of post-graduate pharmacy training in infectious diseases at Lee Health in Fort Myers, FL. She returned to government service in 2014 as the Designated Federal Officer for the FDA’s Oncologic Drugs and Antimicrobial Drugs Advisory Committees. She joined the OCE and the Project Orbis team in 2020. Currently, Lauren manages applications involving foreign regulatory partners under Project Orbis, coordinates international communication, and supports OCE internal planning for advisory committee meetings.
Yinghua Wang is a Senior Health Scientist at the OCE. She holds a Doctor of Pharmacy degree from the University of Maryland Baltimore School of Pharmacy, a Master of Public Health from the Johns Hopkins University Bloomberg School of Public Health, and a Regulatory Affairs Certification. Prior to her FDA tenure, Yinghua was the Managing Editor for a drug information database at Thomson Reuters. Yinghua began her FDA career in 2008 within the Center for Drug Evaluation and Research, serving first as a safety evaluator in the Office of Surveillance and Epidemiology, and later in the Division of Advisory Committee and Consultant Management as a Conflict-of-Interest analyst, Designated Federal Officer, and Branch Chief of Advisory Committee Management. She joined the OCE International team in January 2021, where she manages Project Orbis applications and facilitates engagement with international regulatory counterparts.
Tina MacAulay is a Regulatory Information Specialist at the OCE. Tina joined the FDA/CDER in 2017 as a Project Specialist for the Project Management and Analysis Staff, supporting the Division of Hematology, Oncology Toxicology Products, and the Division of Pharm/Tox of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine. Currently, within the OCE, Tina manages shared information and oversees project implementation for international collaborations, Project Orbis, pharmacy student rotations, ODAC member coordination, and travel.
The U.S. Food and Drug Administration, in partnership with the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC), conducted the first Project Orbis collaborative review. Since that time, additional nations have joined as Project Orbis Partners (POP).
Australian Therapeutics Goods Administration (TGA)
Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária [ANVISA])
Israel Ministry of Health (IMoH) Pharmaceutical Administration
Singapore Health Sciences Authority (HSA)
United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA)
Lee SH, Hotaki LT, Oh K, et al. Index of application status transparency and availability of public information for Project Orbis agencies. Int J Drug Reg Affairs. 2024 Sep. 15;12(3):55-.
Hotaki, L.T., Shrestha, A., Bennett, M.P. et al. Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners. Ther Innov Regul Sci 57, 875–885 (2023).
Matea Zosso-Pavic, Qiyu Li, Eiman Atiek, Anita Wolfer, Ulrich-Peter Rohr. Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis. The Lancet Oncology, 2024, ISSN 1470-2045.
FDA Ground Rounds: Project Orbis by R. Angelo de Claro, MD
FDA News Release: FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
FDA Voices: Strengthening International Collaboration for Oncology Product Reviews, Faster Patient Access to Innovative Therapies
Publication: Project Orbis: Collaborative Review Program
Assessment Aid (AAid) Please contact the review division for the most current template.
Sponsor Authorization Letter (SAL) Template Instructions: FDA Component Contact Name: Office of Oncologic Disease Division Director
Each agency requires a separate authorization and must include the appropriate contacts from the respective agency.
For the [insert description of purpose] section: this should state “…the review by FDA and [ANVISA, HC, HSA, MHRA, IMoH, Swissmedic, TGA] of the
applications.”
For the information to be shared section: this should state, “Any data or information regarding NDA/BLA/supplement xxxxxx”
Project Orbis Request for Participation and Global Submission Plan (GSP)
Project Orbis Approvals (as of April 22, 2026)
Please note: The listing of Type C Project Orbis approvals may be delayed relative to the FDA approval date while necessary documentation, such as global submission plans and sponsor authorization letters, is finalized.
This report is updated on a quarterly basis.
FDA approval dates do not necessarily align with Project Orbis Partner (POP) approval dates.
A product may be approved in a POP country if it was not part of Project Orbis
Australia’s Therapeutic Goods Administration Australian Register of Therapeutic Goods
Prescription medicines registration database
Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária [ANVISA]) Medicines (Portuguese only; use Google Chrome to translate into English)
Health Canada The Drug and Health Product Register
Drug Product Database: Access the database
Israel’s Ministry of Health (Pages below published monthly in Hebrew; use Google Chrome to translate into English) New Drugs
Singapore’s Health Sciences Authority Online Infosearch- Register of Therapeutic Products
Swissmedic Initial approvals of NASs/BLAs
Indication extensions are published in the monthly Swissmedic Journal (SMJ)
Access Consortium work-sharing authorisations
Swiss Database of Product Information for Professionals and Patients
Swiss Public Assessment Reports for New Active Substances
United Kingdom’s Medicines and Healthcare products Regulatory Agency Marketing authorisations
FDA Oncology Center of Excellence
FDA: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review
For additional questions please contact ProjectOrbis@fda.hhs.gov
