Politics & Government

Japan Lays Out Roadmap for Boosting Drug Development; Many Treatments for Cancer, Rare Diseases Still Unavailable

Yomiuri Shimbun file photo
Prime Minister’s Office

The Yomiuri Shimbun

1:00 JST, July 31, 2024

The government has set strategic goals for improving Japan’s drug development and laid out a roadmap for achieving them, details of which have been learned.

The main pillars of the roadmap include starting clinical trials on much-needed drugs by fiscal 2026 and creating at least 10 drug discovery startups by 2028, in order to overcome the “drug lag” problem, in which drugs that have been approved in Western countries cannot be used in Japan.

According to the Health, Labor and Welfare Ministry, there were 86 drugs for cancer or intractable diseases that had been approved in Europe or the United States but not in Japan as of March 2023. Of these, 32, or nearly 40%, are used to treat children.

The government’s five-year roadmap starting in the summer of 2024 sets a goal of selecting urgently needed drugs from these 86 and starting clinical trials for them by fiscal 2026. As for drugs for children, for which drug lag is more serious, the government aims to create 50 new drug development plans over the five years through fiscal 2028. It is also set to ease requirements for drug approval, aiming to encourage pharmaceutical companies to develop new drugs and swiftly deliver them to the public.

Drug discovery has been increasingly led by startup companies in the United States in recent years. In Japan, such startup companies have not been well cultivated, leading the government to set a goal of creating 10 or more startups with a value of more than ¥10 billion by 2028.

Since Japan has not joined in many international joint clinical trials, the government has also set a goal of increasing by 50% the number of such applications to 150 a year.

In fiscal 2025, the government will launch a public-private council comprising officials from foreign pharmaceutical companies, venture capital firms and other organizations to help attract active overseas investment to Japan and develop research centers.