Yasuda Naoyuki stands out as one of Japan’s most influential figures in international pharmaceutical regulation. As Executive Director for International Affairs at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), he has dedicated his career to strengthening Japan’s global presence in healthcare, building partnerships with international regulators, and ensuring patients get timely access to innovative treatments.
Donglei,Mao Editor-in-Chief with Yasuda Naoyuki
A Career Built on Regulatory Excellence
Yasuda began his career at the Ministry of Health, Labour, and Welfare (MHLW), where he developed expertise in pharmaceutical regulation and cross-border coordination. This foundation paved the way for his transition to the PMDA, where he became a key driver of Japan’s push to align with global standards and modernize its pharmaceutical framework.
Key Achievements at PMDA
One of Yasuda’s signature accomplishments has been positioning Japan as a global hub for drug development. Under the leadership of PMDA Chief Executive Dr. Yasuhiro Fujiwara, the agency has taken major steps to reduce the “drug lag”—the time it takes for new drugs to become available in Japan compared to the U.S. and Europe.
A standout milestone was opening the PMDA’s Washington, D.C. office, a move Yasuda championed. This office not only strengthens Japan–U.S. regulatory ties but also provides critical support to American companies navigating Japanese requirements. Yasuda also played a pivotal role in establishing the PMDA Asia Office in Bangkok, which promotes regulatory harmonization and expands training through the Asian Training Centre (PMDA-ATC). Both offices reflect his proactive approach to international collaboration that ultimately benefits patients worldwide.
Championing Global Regulatory Cooperation and Innovation
Throughout his career, Yasuda has stressed the importance of international cooperation in drug regulation. He has consistently advocated for harmonizing Japan’s processes with other major regions to keep pace with the complexities of global drug development.
Central to this effort is PMDA’s leadership in regulatory science. The agency has been at the forefront of using Real-World Data (RWD) and Real-World Evidence (RWE) to inform regulatory decisions. As of early 2025, Japan had approved eight new drugs based on RWE as external control evidence, especially in rare diseases and cancers where traditional trials are difficult. PMDA also operates the Medical Information Database Network (MID-NET), which uses electronic health records and claims data to monitor drug safety post-approval. Programs like the Sakigake (“Pioneer”) designation further accelerate the review of innovative medical products.
Yasuda sees Japan as a “balancer”—its regulatory system is both rigorous and flexible, able to incorporate global clinical data while upholding high safety and efficacy standards. By aligning more closely with the U.S., Europe, and other leaders, Japan can speed up patient access to new therapies without compromising quality.
Engaging China as a Key Partner
Yasuda also recognizes China’s growing role in pharmaceutical regulation. He frequently works with the National Medical Products Administration (NMPA) to encourage Chinese companies to submit Investigational New Drug (IND) and New Drug Applications (NDA) to Japan. Yasuda envisions deeper collaboration between PMDA and NMPA, enabling innovative medicines from China to reach patients in both countries more efficiently. “This collaboration isn’t just about faster approval,” he says, “but about ensuring that patients truly benefit from new therapies as soon as possible.”
PMDA at 20: Looking Back and Ahead
On April 1, 2024, the PMDA marked its 20th anniversary. Over two decades, it has grown from a team of 250 to more than 1,000 staff, becoming a global leader in drug and device review, post-market safety, and patient relief services. Central to its success is the “safety triangle”—an integrated approach to pre-market review, post-market monitoring, and patient support. This model has earned the PMDA international recognition for both scientific rigor and patient-centered care.
Looking forward, Yasuda envisions a PMDA even more embedded in the global regulatory community. International offices in Washington and Bangkok are key to harmonizing standards, improving data sharing, and further reducing drug lag. He also highlights the continued importance of regulatory science innovations, like the Sakigake system, and expanding training across Asia to maintain PMDA’s leadership in regulatory practice.
A Vision for Japan’s Role in Global Healthcare
At the heart of Yasuda’s leadership is a strong sense of social responsibility. Every initiative—from opening overseas offices to advancing regulatory science—has been driven by a patient-first philosophy. He has helped Japan become not just a consumer, but a contributor and leader in global pharmaceutical innovation.
While challenges remain, such as Japan’s traditional caution toward foreign clinical trial data, Yasuda has championed a more flexible approach. “When foreign clinical data shows only minor differences from Japanese data, the PMDA will accept it,” he explains. His stance reflects an evolving agency that values both scientific rigor and practical flexibility.
Yasuda Naoyuki’s career exemplifies the impact of global cooperation and visionary leadership in healthcare. As the PMDA celebrates its 20th year, his influence is evident in the agency’s achievements and its ambitious vision for the future. Through championing international partnerships, regulatory harmonization, and a patient-centered mission, Yasuda has helped define Japan’s role as a driving force in global drug development—and his leadership will shape the future of healthcare for years to come.
Edited by：Justin Fischer