ANN/THE JAPAN NEWS – Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is gearing up for a significant international move, with plans underway to establish a US base by the fiscal year ending March 2025.
This strategic initiative aims to bolster PMDA’s global presence and by setting up an office in the US, independent administrative agency intends to entice American drug discovery startups to explore drug development opportunities in Japan.
The agency will offer complimentary consultations, aiding startups in navigating the Japanese approval process and providing a range of essential services.
Furthermore, Japan’s Health, Labour, and Welfare Ministry are orchestrating a close collaboration between PMDA and the US Food and Drug Administration.
This partnership aims to eradicate a longstanding issue: the avoidance of introducing newly approved pharmaceuticals from Western nations into Japan. The joint effort seeks to streamline processes, ensuring that valuable medical advancements do not bypass the Japanese market.
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 DC is a candidate city for the PMDA’s US office. The agency plans to have Japanese staff members as well as locally hired staff, the sources said.
The US 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 US 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 US pharmaceutical company seeks approval for a drug in Japan, the PMDA’s US office will plan to provide advice on how to conduct clinical trials, the sources said.
The US office will also assist in the dispatch of staff from Japan to the US and deal with issues through online means.
The ministry has included a related budget of JPY66 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 per cent are from startup companies.
In many cases, drug discovery startups are able to obtain approval only in the US and Europe.
After the US and China, Japan has the largest pharmaceuticals market at about JPY10 trillion, but language barriers and other factors have been cited as reasons why some companies have not entered the Japanese market.
Using the US 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.
