Introduction to Project Orbis
is an international regulatory collaboration program established by the FDA Oncology Center of Excellence (OCE) in May 2019 to enable the concurrent submission and review of oncology products among participating regulatory authorities. The initiative was created to facilitate earlier patient access to innovative cancer therapies by allowing regulators to review applications in parallel rather than sequentially across different countries.
Given that many pivotal oncology clinical trials are now conducted globally, Project Orbis aims to improve regulatory collaboration, harmonize scientific assessments, and support more efficient development and approval pathways for cancer medicines worldwide. Since its launch, the program has supported numerous oncology submissions and approvals across participating jurisdictions.
How Project Orbis Works
Project Orbis provides a structured framework through which sponsors can submit oncology marketing applications concurrently to multiple health authorities. Participating agencies conduct coordinated reviews and exchange information throughout the assessment process while maintaining their own independent regulatory decisions.
This collaborative approach can:
Strategic Importance for Global Oncology Development
The increasing globalization of oncology drug development has made simultaneous regulatory engagement more important than ever. Project Orbis allows sponsors to align submission strategies across multiple markets and potentially achieve approvals in several countries within a narrower timeframe.
For regulatory affairs teams, participation in Project Orbis may help streamline global filing plans, facilitate regulator-to-regulator communication, and reduce the risk of significant approval timing gaps between major markets.
Japan’s Participation in Project Orbis
On September 10, 2026, the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) formally joined as full participants. Japan had previously participated as an observer since 2022.
Through full participation, and will be able to engage more closely with the and other international regulatory authorities during the review of new oncology products, allowing deeper scientific exchange and coordinated regulatory assessments.
Addressing Drug Lag and Drug Loss in Japan
A key objective of Japan’s participation is to reduce so-called “drug lag” and “drug loss” in oncology, where innovative cancer medicines become available substantially later in Japan than in other major markets. and have stated that participation in Project Orbis will strengthen collaboration with the , promote earlier oncology development activities in Japan, and facilitate coordinated reviews of eligible oncology products.
By integrating Japan more directly into an established international review network, the initiative is expected to improve the attractiveness of Japan as a launch market for innovative oncology therapies and encourage inclusion of Japan in global regulatory and development strategies.
Expansion of the Global Regulatory Network
Prior to Japan’s accession, Project Orbis included regulatory authorities from the United States, Canada, Australia, the United Kingdom, Switzerland, Singapore, Brazil, and Israel. Japan now becomes an additional full participant in the program after several years of observer involvement.
The inclusion of Japan expands Project Orbis into one of the world’s largest pharmaceutical markets and further strengthens the program’s role as a key platform for global oncology regulatory collaboration.
Implications for Regulatory Affairs Professionals
For companies developing oncology products, Japan’s participation may create new opportunities to include Japan within synchronized global submission strategies.
Potential benefits include:
Sponsors developing products eligible for Project Orbis should consider whether future global submission plans could incorporate Japan as part of a coordinated regulatory strategy.
Conclusion
has evolved into one of the most important international regulatory initiatives in oncology, providing a framework for concurrent review and approval of cancer therapies among multiple health authorities. With the formal participation of and , Japan is taking a significant step toward reducing oncology drug lag and integrating more closely into global regulatory review processes.
For global regulatory affairs professionals, Japan’s entry into Project Orbis represents a meaningful development that may enhance the feasibility of synchronized oncology submissions and accelerate patient access to innovative cancer treatments across multiple regions.
Reference
厚生労働省及びPMDAはProject Orbisに参加します ～抗がん剤領域におけるドラッグラグ・ロスの解消を目指します～｜厚生労働省