MHLW and PMDA Join Project Orbis to Close Anticancer Drug Lags and Losses
Overview
On September 10, 2026, the Ministry of Health, Labour and Welfare and PMDA decided to formally join Project Orbis, an international cooperation framework for the regulatory review of anticancer drugs led by the U.S. FDA. They aim to eliminate drug lags and losses in the anticancer drug field by strengthening information exchange with overseas regulatory authorities on new anticancer drugs, promoting Japan-U.S. collaboration and development in Japan, and advancing collaborative reviews of eligible products.
Key points
- The Ministry of Health, Labour and Welfare and PMDA decided to formally join Project Orbis.
- They will be able to engage in closer information exchange with overseas regulatory authorities on the regulatory review of new anticancer drugs.
- They aim to eliminate drug lags and losses in the anticancer drug field.
Overview
The Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency (PMDA) decided to formally join Project Orbis, an international cooperation framework for the regulatory review of anticancer drugs led by the U.S. Food and Drug Administration (FDA).
Through this participation, they will deepen Japan-U.S. collaboration in the anticancer drug field, promote development in Japan, and advance collaborative reviews with the FDA of products covered by Project Orbis.
Impact
They aim to promote anticancer drug development in Japan and collaborative reviews with the FDA of products covered by Project Orbis, thereby eliminating drug lags and losses in the anticancer drug field.
Together with PMDA, the Ministry of Health, Labour and Welfare will continue efforts to eliminate drug lags and losses and cooperation with pharmaceutical regulatory authorities in other countries.
Details
Project Orbis is an international cooperation program for the regulatory review of anticancer drugs launched in May 2019 by the FDA's Oncology Center of Excellence (OCE).
In addition to the United States, the regulatory authorities of Canada, Australia, the United Kingdom, Switzerland, Singapore, Brazil, and Israel formally participate. Japan has participated as an observer since 2022.
With this formal participation, they will be able to engage in closer information exchange with the FDA and other overseas pharmaceutical regulatory authorities during the regulatory review of new anticancer drugs.