Regulatory science in Japan: concept and practice through PMDA

Why regulatory science matters in Japan

In Japan’s life-sciences ecosystem, “regulatory science” (RS) is positioned as the discipline that helps society adopt new technologies responsibly. PMDA describes its core mission across three services—approval reviews, post-marketing safety measures, and relief services for adverse health effects—and emphasizes that RS activities strengthen the quality and credibility of these services.¹

PMDA’s Regulatory Science Activity Report (released in December 2024) frames RS not as a purely academic pursuit, but as an operational capability: improving decision-making in review and safety, supporting innovation from development consultations through post-market stages, and contributing to international harmonization.²

What “regulatory science” means (Japanese context)

PMDA cites the Science, Technology, and Innovation Basic Plan’s definition of RS as a science that makes precise prediction, evaluation, and judgment based on evidence, adapting technological achievements to social and human needs in an optimal way.³ The report also references a PMDA-related academic framing: RS as a science aimed at the optimal introduction into society of new products and tools of science, as well as knowledge and information.⁴

Taken together, the Japanese framing emphasizes:

• Evidence-based judgment (prediction, evaluation, decision)
• Societal fit (technology aligned with human needs)
• Translation to practice (from research outcomes to real-world use)

How PMDA operationalizes regulatory science

1) Governance and organizational capability: the RS Center

PMDA established its Regulatory Science (RS) Center in April 2018 to further promote RS and improve the quality of approval reviews and post-marketing safety measures.⁵ The report notes a reorganization in July 2023 to strengthen PMDA’s internal RS research system, with the RS Center organized into four divisions:

• Office of Regulatory Science Coordination
• Office of Regulatory Science Research
• Office of Research Administration
• Office of Medical Informatics and Science⁵

This structure matters because RS is not confined to one function. The RS Center is described as working cooperatively with PMDA’s review and safety divisions and with external organizations, so that RS results can be applied to PMDA operations.⁵

2) Annual planning and publication: making RS visible and reusable

The report states that PMDA’s Fifth Mid-Term Plan began in FY2024, aiming to further promote RS research and proactive dissemination of RS-related information.² It also describes this activity report as the first of a yearly series, and highlights PMDA’s publication of “Early Considerations” as reference information to promote practical application of innovations, along with dissemination efforts such as staff-explained videos.²

3) Human resource development: partnerships and joint graduate school frameworks

A recurring theme is capacity building. PMDA describes collaboration frameworks with universities and research institutions—through comprehensive partnership agreements and, in some cases, joint graduate school agreements—covering activities such as personnel exchange, joint research, dispatching faculty, and support for degree acquisition.⁶ The stated goal is to develop people who can lead RS discussions and to strengthen mutual understanding between regulators and external research communities.⁶

4) Expert deliberation: the Science Board

PMDA describes the Science Board as a body of external experts with diverse expertise to deliberate scientific aspects of PMDA operations (reviews and safety measures) for drugs, medical devices, and regenerative medical products.⁷ In practical terms, this helps the agency handle emerging scientific questions by bringing multidisciplinary perspectives into regulatory decision-making.

What this means for industry and academia

For companies, Japan’s RS approach signals that regulatory expectations increasingly revolve around transparent scientific rationale and traceable evidence, especially when technologies are novel. For academia, the approach signals opportunities—and responsibilities—to generate evaluation methods and evidence that can be translated into guidance and practical regulatory decision-making.

Q&A (practical questions)

Q1: What is “regulatory science” in Japan, in one sentence?

It is an evidence-based discipline for making precise prediction, evaluation, and judgment so that scientific and technological achievements can be introduced into society in an optimal way.^{3 4}

Q2: Why does PMDA emphasize RS as part of its core work?

Because RS strengthens the quality of PMDA’s services—approval reviews, post-marketing safety measures, and relief services—while supporting innovation and reinforcing public trust.^{1 2}

Q3: What is the role of PMDA’s RS Center?

The RS Center is PMDA’s organizational hub for advancing RS, coordinating across PMDA and with external partners, and applying research outcomes to improve review and safety operations.⁵

Q4: How does PMDA build RS talent in Japan?

PMDA uses collaboration frameworks with universities and research institutions (including comprehensive partnership agreements and joint graduate school agreements) to support personnel exchange, joint research, training/education, and other capacity-building activities.⁶

Q5: How are external experts involved in PMDA’s scientific decision-making?

Through the Science Board, which consists of external experts and deliberates scientific aspects of PMDA operations related to reviews and safety measures.⁷

Q6: How can developers of novel products use this information practically?

Treat RS as a development strategy: document your scientific rationale, generate evidence tailored to risk and novelty, and align your evaluation approach with how regulators must make evidence-based judgments under Japan’s system.^{2 5}

References