Outline of Regulatory Science

PMDA’s scientific activities must consist of accurate prediction, evaluation, and judgment based on clear evidence, while incorporating the latest scientific findings.
To improve such activities, it is important to advance regulatory science, which forms the basis of regulatory activities.

PMDA is committed to promoting regulatory science and fostering regulatory scientists through expansion of training programs for employees, implementation of research on PMDA’s three services (product reviews, safety measures, and relief services for adverse health effects), utilization of the Science Board, and education by way of the Collaborative Graduate School Program.

Under the Initiative to facilitate development of innovative drugs, medical devices, and cellular and tissuebased product, personnel exchanges between PMDA and universities/research institutions has been enhanced since fiscal 2012.
Through this approach, PMDA endeavors to establish methods of evaluating the safety and efficacy of innovative drugs, medical devices, and cellular and tissue-based products and thus to develop guidelines, while nurturing human resources who are wellversed in innovative technology and regulatory science.

What Is Regulatory Science?

• Regulatory science plays an important role in adapting the achievements of technology to social and human needs in the most optimal way, by making precise prediction, evaluation and judgment based on evidence.

(Source: Basic Program for Science and Technology [approved by the Cabinet on August 19, 2011])

• When a product obtained as a result of the medical research and development is applied to practical use, regulatory science contributes to making appropriate and prompt prediction, evaluation and judgment of the quality, efficacy and safety of the product in light of scientific findings.

(Source: Article 13, paragraph 2 of the Act to Promote Healthcare and Medical Strategy)