Cabinet Office to Support Overseas Expansion of Companies Developing Drugs to Treat Rare, Intractable Diseases

The Yomiuri Shimbun

13:48 JST, March 8, 2026

The Cabinet Office will this year begin supporting overseas expansion by startups and midsize companies developing drugs to treat intractable or rare diseases, in an effort to strengthen the nation’s pharmaceutical development capabilities. It will subsidize the costs of participating in simultaneous domestic and foreign clinical trials to confirm the efficacy of such drugs.

Getting a drug approved requires confirming that it is safe and effective through clinical trials in the countries where it is to be sold. For drugs that may target rare diseases with few patients, conducting clinical trials in several countries simultaneously allows for the collection of data needed to confirm that a particular treatment is effective, enabling it to be swiftly delivered to patients.

However, clinical trials can cost billions of yen or more to conduct, often making it difficult for startups with limited financial resources to join in multiple simultaneous trials in Japan and overseas.

The Cabinet Office will provide subsidies to Japanese startups and midsize firms that plan to join in international clinical trials. This will help to cover preparatory costs such as those required to look into the number of overseas patients and to consult with regulatory bodies, as well those of actually implementing trials.

The support will be targeted at firms that aim to sell drugs of this kind in Japan. By fiscal 2027, the Cabinet Office plans to support about 5 companies implementing clinical trials and 10 more making the necessary preparations to do so.

The Cabinet Office earmarked ¥12 billion for costs related to this initiative in its supplementary budget for fiscal 2025.

Such support is envisaged to be offered in cases such as when a startup joins in simultaneous clinical trials in Japan, the United States and Europe for a drug developed with technology originating from Japanese universities.

The Cabinet Office may also support domestic firms that hold clinical trials simultaneously in Japan and other Asian countries for drugs already in use in the United States and Europe. The firms would also need to have acquired sales rights for the drugs. This is expected to help address “drug loss,” the phenomenon of in which pharmaceuticals do not become available in Japan although they are approved in the United States and European countries.

According to the Health, Labor and Welfare Ministry, as of March 2023, there were 86 drugs which were approved overseas but not yet developed for use in Japan, 40 of which were for rare diseases.