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Yomiuri Shimbun file photo The Health, Labor and Welfare Ministry building in Tokyo
The Yomiuri Shimbun
1:00 JST, September 28, 2023
A U.S. base is being planned for Japan’s Pharmaceuticals and Medical Devices Agency, to open in the fiscal year ending March 2025, to strengthen the PMDA’s overseas strategy, according to sources.
Having an office in the United States is expected to help the PMDA attract U.S. drug discovery startups to develop drugs in Japan. The agency will provide free consultations on how to apply for approval in Japan, among other services.
The Health, Labor and Welfare Ministry also intends for the PMDA to work closely with the U.S. Food and Drug Administration to eliminate drug loss, in which new pharmaceuticals approved in Western nations do not enter Japan, the sources said.
The PMDA is an independent administrative agency under the ministry’s jurisdiction. It is responsible for the approval and review of pharmaceuticals, medical devices and regenerative medical products on behalf of the ministry. The agency also advises companies, universities and research institutes on clinical trials and applications for approval.
Washington, D.C. is a candidate city for the PMDA’s U.S. office. The agency plans to have Japanese staff members as well as locally hired staff, the sources said.
The U.S. office is to participate in business meetings and conferences where startup executives gather, and it plans to disseminate information in English. The idea is to promote the attractiveness of Japan, which has many similarities to the United States in terms of clinical trials and procedures required for drug approval, as well as a system for the rapid approval of highly effective drugs.
When a U.S. pharmaceutical company seeks approval for a drug in Japan, the PMDA’s U.S. office will plan to provide advice on how to conduct clinical trials, the sources said. The U.S. office will also assist in the dispatch of staff from Japan to the United States and deal with issues through online means.
The ministry has included a related budget of ¥66 million in its budget request for fiscal 2024.
In recent years, there have been increasing cases of drugs approved in Western nations but not in Japan, according to the ministry and other organizations.
Also, of the 86 drugs for cancer and other intractable diseases approved in Europe and the United States between 2016 and 2020, 48 of them, or 56%, are from startup companies.
In many cases, drug discovery startups are able to obtain approval only in the United States and Europe.
After the United States and China, Japan has the largest pharmaceuticals market at about ¥10 trillion, but language barriers and other factors have been cited as reasons why some companies have not entered the Japanese market.
Using the U.S. office as a base, the ministry intends to actively promote drug development in Japan by building relationships with local companies.
The ministry plans to act as a guide to help such companies obtain approval for new drugs in Japan.
During the same time frame, the ministry also plans to open a PMDA overseas office in Asia, with Bangkok as a possible location.
