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Japan, with a population of 125 million people, is the world’s fourth largest economy and the fourth largest pharmaceutical market in 2025. Its medical product regulators are considered among the top regulatory authorities worldwide. To better understand Japan’s approach to medical product regulation, the FDA’s Office of Global Policy and Strategy recently spoke with Dr. Daisaku Sato, Councilor for Pharmaceutical Affairs in Japan’s Ministry of Health, Labour and Welfare (MHLW) and Dr. Yasuhiro Fujiwara, Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the country’s regulatory counterpart to the FDA. The two men were in Washington, D.C., for meetings at the FDA and elsewhere.
Thank you for agreeing to speak with us. You, Dr. Fujiwara, are the Chief Executive of Japan's Pharmaceuticals and Medical Devices Agency, a position you’ve held since 2019. Could you explain how PMDA’s oversight of medical products differs from the FDA's?
Fujiwara: Thank you very much for having an opportunity to talk with the FDA. PMDA is Japan's regulatory authority for pharmaceutical and medical devices, serving as the direct counterpart to the FDA. We are an incorporated administrative agency, a governmental body operating under the jurisdiction of the Ministry of Health, Labour and Welfare. Last spring we marked our 20th anniversary, and as the third chief executive, I'm now in my seventh year in the role. What makes PMDA unique is that we are the world’s only public agency to integrate three core functions — application review, safety measures, and relief for adverse health injuries. In particular, our patient relief program for those suffering from adverse health effects associated with pharmaceuticals and related medical products is a distinct feature not found in other regulatory agencies.
Just like the FDA, we have both standard and some form of expedited review such as priority review for orphan products. A key difference from the FDA's review system is that in Japan, PMDA submits its review results to the Advisory Council in the Ministry of Health, Labour and Welfare, and the Minister of Health, Labour and Welfare grants marketing authorization for pharmaceuticals and medical devices based on the Advisory Council's opinion. Regarding our regulatory philosophy, we place a strong emphasis on a high degree of transparency and science-based assessment in all of our daily work. Moreover, PMDA is recognized as one of the world’s three leading regulatory authorities alongside the FDA and the European Medicines Agency. We are actively promoting international harmonization through ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] and IMDRF [International Medical Device Regulators Forum]. Given this perspective, I believe there are no fundamental differences in our relative philosophies between Japan and the United States.
You are here in Washington for the inaugural ceremony of PMDA's Washington, D.C., office. We understand this is the agency’s second foreign office. You opened your first in Bangkok, Thailand, last year in July. Could you explain why you've decided to open an office in Washington and what you hope to achieve by maintaining an office here?
Fujiwara: One of the key priorities of PMDA is to globalize our operations further. I strongly believe not just waiting in Japan — we must proactively go abroad and promote regulatory harmonization through direct dialogue with our international counterparts. In recent years, more and more overseas entities are leading the development of innovative pharmaceuticals and medical devices, particularly startups and venture companies in the United States. Thus, in Japan, it is necessary to help such companies develop pharmaceuticals and medical devices rapidly in Japan as well. It is also important for PMDA to provide such startups and other overseas companies with information on Japanese regulations, as well as our efforts toward the practical application of pharmaceuticals and medical devices to clinical practice.
To this end, PMDA has established a new office in Washington, D.C. The office serves as a point of contact for collaboration between Japanese and U.S. government agencies, including the FDA. Close collaboration is essential to advance regulatory harmonization and to facilitate the development of innovative products as well as enhance our review process and post market safety measures. Moreover, our D.C. office will provide general consultation services in English for U.S. startups and major companies who are interested in development in Japan. In this way the office aims to become a one-stop place for responding to Japanese pharmaceutical regulatory matters.
Furthermore, the staff of the D.C. office is not only participating in various academic conferences and events held in United States but also having direct contact and connection with the relevant academic organizations, enterprises, contract research organizations, etc. The staff will expand its network to clearly explain the Japanese regulatory system for pharmaceuticals and medical devices, introduce advantages in developing pharmaceuticals and medical devices in Japan, and intend to have an exchange of views with those relevant stakeholders. I hope that regulatory cooperation between Japan and the United States can be further enhanced through the D.C. office. By promoting access to innovative pharmaceuticals and medical devices that originate from the United States, I also contribute to PMDA’s purpose — making everyone's lives brighter together.
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The U.K.-based nonprofit Center for Innovation and Regulatory Science (CIRS) issues an annual report on new drug approvals by six major regulatory authorities, the FDA, Health Canada, Swiss Medic, the Australian Therapeutic Goods Administration, the European Medicines Agency, and PMDA. The report focuses on median approval times. While this data can be a marker of agency performance and the time it takes to make medicines available to patients, other factors must be considered, the organization cautions.
In 2024, PMDA had the shortest median approval time for new drug approvals of the six regulatory authorities — 290 days —according to CIRS, followed by the FDA with 356 days. PMDA also achieved the shortest median approval time for orphan drugs of the six authorities. To clarify, these numbers take into account Japan's two-step drug approval process that begins with PMDA’s review of the submission followed by MHLW approval that you've explained already. I’d like to ask both of you to discuss this data. Let’s begin with you, Dr. Fujiwara.
Fujiwara: One of PMDA’s principles is, we’ll be the bridge between the patients and their wishes for faster access to safer and more effective pharmaceuticals and medical devices. In the past, reviews in Japan took longer, and that was criticized as a reason for delays in approval in Japan. Because of this, we increased the number of reviewers and made efforts to improve review abilities and efficiencies. PMDA began in 2004 with just about 250 staff, but we have grown into an organization of more than 1,000 experts. In addition, we offered consultations for various stages in the development period so that we can communicate with developers earlier in development. Such communication includes agreements on non-clinical data necessary for approval application and clinical trial designs. I think that those efforts resulted in smooth reviews and consequently, our review times became shorter.
Sato: My name is Daisaku Sato, Councilor for Pharmaceutical Affairs in the Ministry of Health, Labour and Welfare. I'm responsible for the pharmaceutical program at the Ministry. Thank you very much today for the opportunity to speak here. MHLW supervises the legal framework for the approval, manufacturing and marketing of medical products, and compliance activities involving manufacturers and marketing authorization holders. At the same time MHLW gives financial and operational support to PMDA's review process.
As mentioned by Dr. Fujiwara, in the process of approval of medical products, PMDA submits its review results to the Minister of Health, Labour and Welfare via its Advisory Council, and the Minister grants authorizations for pharmaceuticals and medical devices based on the Advisory Council's opinion. And while MHLW has the authority to make administrative decisions, it operates the review process efficiently in an integrated manner with PMDA in terms of management and coordination. We keep close communication with PMDA and the applicant company in a timely manner. For example, we convene advisory councils 20 times a year to ensure that the new products arrive to the public without delay.
Looking again at this report, while PMDA’s approval times are shorter than its five other regulatory counterparts, there is a substantial submission gap, that is, the period of when a company submits their first application to one of the six regulatory authorities, typically the FDA, before they submit that application to PMDA. In 2024, the submission gap was 1,427 days. Could you discuss this trend and what you're trying to do to bridge the gap?
Fujiwara: I see that one of the reasons for the delay in application submissions in Japan is that there is a delay in timing on the overseas company’s side to decide whether to develop in Japan. I think that is because those companies do not have information related to Japanese regulations and the Japanese market, or they do not understand the information correctly. In addition, since the development of many orphan and pediatric drugs are delayed in Japan, I think we need to provide support for the development of those drugs. As I mentioned before regarding the D.C. office, we currently provide general consultation services there and an outreach information program to academic conferences and events in the United States. We proactively carry out activities outside Japan, aiming to promote understanding of the Japanese regulatory system.
Furthermore, last year PMDA established a Center for Regulatory Consultation of Pediatric and Orphan Drugs and through consultation at this center, we support the development of orphan drugs and drugs for pediatric usage.
Sato: I will add some words from the policy perspective on drug regulations. The Japanese government is pursuing a policy to accelerate patient access to innovative medicines for unmet medical needs through facilitating research and development proactively in Japan as well as through regulatory reform so as to catch up to the drug product gap and loss between the U.S. and Japan. We keep a patient-centric approach to ensure treatment access not only in Japan but also in other regions, including the United States.
We have been responding to the internationally harmonized Good Clinical Practice (GCP) revisions and working to improve the clinical trial environment in Japan, in an internationally harmonized way, to facilitate implementation of multiregional clinical trials in Japan. I hope it will contribute to facilitating expedited global development of new medicines for wider patient populations overseas and it helps to make Americans healthy in the long run.
Further, we have removed the regulatory barriers in terms of the Japanese clinical data for initiating enrollment of Japanese patients in multiregional clinical trials. We have notified that domestic Phase I studies were not required in principle. We hope that this will enhance the predictability of development in Japan.
In addition, we have clarified two requirements: one is the designation criteria for orphan drugs, and the other is the requirement of additional Japanese data when confirmatory trials were conducted overseas. We have improved the environment to make it easier for Japanese submission as well as global development.
Most of those reforms that you're citing have happened in the last few years, is that correct?
Sato: Yes, in the last few years.
Could you share a few of your most notable collaborations with the FDA?
Fujiwara: Japan-U.S. cooperation is multilayered, ranging from collaboration in multilateral frameworks to bilateral partnership. Since the inception of ICH in 1990, Japan and the United States have been participating in discussions on the international harmonization of pharmaceutical regulations and leading its activities together, as founding regulators. Both countries have been playing major roles for many years as a chair and vice chair of the ICH Management Committee. Moreover, in the medical devices area, both of us have been leading discussions on global regulatory harmonization in the IMDRF. In 2024, the U.S. was the chair of the IMDRF and this year, in 2025, Japan took on the role of the chair. In addition, both Japan and United States are participating in various clusters such as the oncology area, pharmacovigilance, ATMP [advanced therapy medicinal products], and GCP to share information and exchange views regularly. There are confidential commitments between Japan and United States to cooperate closely with each other. Both countries exchange in confidence the information related to consultation, reviews, and safety measures.
Specifically, in the area of medical devices, through the initiative called harmonization by doing or “HBD” — industries, governments, and academia in both countries are working in tandem to promote regulatory harmonization on medical devices, focusing on clinical trials and review practices. This initiative resulted in various accomplishments such as solutions to challenges in multiregional clinical trials and its promotion, harmonization in data registries, and development of evaluation guidance. In such a way, both Japan and the United States have been collaborating closely as well as leading global regulatory harmonizations.
As a follow-up, tell us something about how you regulate medical devices. Is there considerable similarity between how you regulate devices and how FDA regulates devices?
Fujiwara: Very similar.
Sato: But we have a third-party notification system as well. And one thing I have to add is that we have had a collaboration with the FDA for the last 10 years in the PIC/S [Pharmaceutical Inspection Co-operation Scheme] framework for inspections.
We’d like to close by asking what you see as the future of the PMDA-FDA relationship?
Fujiwara: I recognize Japan and the United States have shared objectives and strategies in the regulatory area — that is to promote patient-centric health care, fully leverage scientific and technical process, and swiftly provide safer and more effective treatments. To achieve these objectives, I consider the following approaches, which are also common to Japan and the United States: First to ensure safety and efficacy of drugs, second, modernize reviews and safety monitoring with the use of big data and AI, third, accelerate access to innovative treatment, and finally, rebuild transparency and public trust. Specifically, those approaches include elements such as the use of real-world evidence, real-world data, initiatives to reduce animal testing and regulatory response to the development of pharmaceuticals for rare disease and pediatric disease. PMDA intends to continue Japan-U.S. cooperation through bilateral or multilateral collaborations, achieving such shared objectives and strategies, and contribute to the enhancement of public health in both countries and around the world.
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