Interview with Dr. Akihiro Ishiguro, Head of Pharmaceuticals and Medical Devices Agency (PMDA), Washington D.C. Office

19 Mar Interview with Dr. Akihiro Ishiguro, Head of Pharmaceuticals and Medical Devices Agency (PMDA), Washington D.C. Office

How does PMDA balance strict regulation with accelerating patient access to safe and effective medicines and devices?

Akihiro Ishiguro: PMDA ensures the safety and effectiveness of pharmaceuticals and medical devices through three pillars: providing relief for health damage caused by drugs, reviewing products from early research to approval, and monitoring them post-market. It also supplies scientific evidence to Japan’s Ministry of Health, Labour and Welfare to support public health policy. As more innovative drugs emerge from universities and startups, Japan faces “drug loss,” where products approved overseas are not developed domestically. Under its fifth mid-term plan (2024–2028), PMDA is implementing regulatory measures to address this while accelerating access to innovation. All decisions are grounded in regulatory science to ensure efficacy, safety, and quality, with transparency maintained through Management Council reporting. PMDA balances adopting new technologies with strict regulation to sustain public trust.

How does PMDA ensure transparency and trust in its approval and safety processes while handling sensitive information?

Akihiro Ishiguro: PMDA is strengthening governance and building specialized expertise, including IT talent, to improve efficiency and meet societal expectations. Its fifth mid-term plan focuses on three strategies: enhancing decision-making to ensure transparent and efficient implementation of executive decisions under governing council oversight; fostering a disciplined workplace aligned with an updated code of conduct; and strengthening risk management through proactive information sharing and integration into daily operations. These measures ensure PMDA operates responsibly, transparently, and in line with its public mandate.

How is PMDA evolving its regulatory science capabilities to keep pace with emerging medical technologies and innovations?

Akihiro Ishiguro: PMDA has expanded its regulatory science capabilities through new structures and initiatives. The Regulatory Science Center, established in 2018, supports scientific operations, while the Office of Regulatory Science Research, launched in July 2023, strengthens in-house research and collaboration. In June 2024, the RS Strategic Committee was created to address cross-departmental challenges and guide policy. PMDA also engages academia, industry, and stakeholders through symposiums and roundtables to support early consideration of emerging technologies. Patient engagement remains central, with dedicated working groups, accessible materials, and direct dialogue with patients, particularly those with rare diseases. Together, these efforts enhance scientific rigor, operational quality, and patient-centered decision-making.

How do accelerated pathways like SAKIGAKE and conditional approval support innovation while maintaining a strong risk–benefit balance?

Akihiro Ishiguro: PMDA is promoting pharmaceutical development in Japan through regulatory reforms. In January 2024, revised orphan drug designation criteria more than doubled designations, with many expected to progress to applications. A new conditional approval system, effective May 2026, will enable earlier access to innovative drugs, supporting wider use and encouraging innovation. At the same time, PMDA works closely with stakeholders to ensure appropriate clinical use, with safety and effectiveness carefully monitored after market entry.

What role does PMDA play in advancing regulatory harmonization in Asia and globally, and how does this support innovation and collaboration?

Akihiro Ishiguro: In July 2024, PMDA opened an Asian office in Bangkok to strengthen regulatory harmonization with ASEAN countries. The office collaborates with local authorities, the Ministry of Health, Labour and Welfare, and PMDA headquarters to align pharmaceutical regulations. This has increased Southeast Asian participation in global forums such as ICH and IMDRF, helping build a shared regulatory foundation. The office also engages with regional clinical trial sites alongside Japanese institutions, improving alignment and communication, which has been well received by partner authorities.

What message would PMDA like to share with global readers about Japan’s regulatory environment and its role in fostering innovation, safety, and public trust?

Akihiro Ishiguro: Established in 2004 with around 200 staff, PMDA has grown to approximately 1,500 and continues to evolve in response to global challenges. In April 2024, it defined a new purpose—“making everyone’s lives brighter together”—led largely by younger staff, reflecting a commitment to inclusivity and health equity. Supported by over 600 ideas shaping its organizational culture and formalized values in January 2025, PMDA is strengthening its role by working openly with stakeholders and ensuring reliable execution across its review, safety, and relief functions.

How does PMDA’s relationship with the United States and the FDA support global access to safe and effective medical products?

Akihiro Ishiguro: PMDA maintains close cooperation with the U.S. FDA at both multilateral and bilateral levels. As founding members of ICH, Japan and the United States have led global pharmaceutical harmonization, while PMDA also plays a key role in medical device regulation through IMDRF. The two authorities share information on consultations, reviews, and post-marketing safety under confidentiality commitments, and collaborate on areas such as pediatric anticancer drug development. This partnership strengthens international harmonization and improves global access to safe and effective medical products.

How does PMDA support U.S. pharmaceutical and medical device companies in navigating Japan’s regulatory system and entering the market?

Akihiro Ishiguro: The PMDA Washington, D.C. office, established in November 2024, supports U.S. biotech and startup companies by providing Japanese regulatory information and building local networks. Since March 2025, it has offered free English-language consultations on Japan’s regulatory system, conducting 15 sessions by February 15, 2026. The office also collaborates with the Japan External Trade Organization (JETRO) to support business-related needs and enhance engagement with small U.S. companies. Its September 2025 opening ceremony, attended by U.S. HHS and the FDA, strengthened government ties. Through these efforts, PMDA is expanding its presence and support for U.S. industry.

What is your final message to USA Today readers? 

Akihiro Ishiguro: PMDA is strengthening international engagement to improve patient access to high-quality medical products developed worldwide. The Washington, D.C. office plays a key role by building networks with stakeholders, including U.S.-based accelerators, to support the development and approval of pharmaceuticals and medical devices in Japan. Companies seeking regulatory approval are encouraged to engage with the office.