Overview

The Regulatory Science research area studies the scientific foundations of safety and efficacy assessment and regulatory decision-making, ensuring that healthcare technologies—such as medical devices and pharmaceuticals—reach patients safely and effectively. Grounded in the analysis of preclinical and clinical data and in risk–benefit assessment, we develop evidence-based evaluation methodologies, and—drawing on good practices such as GCP and GLP, international standards such as ISO 13485, and the relevant laws and regulations—we address the entire lifecycle of a medical technology, from development through approval to post-market surveillance. We further leverage real-world data (RWD) and AI-based analytics to enhance the objectivity and efficiency of regulatory evaluation, and we support the timely and safe adoption of emerging technologies through global regulatory harmonization and policy research. Ultimately, this research area aims to secure the safety and reliability of healthcare technologies through convergence research spanning engineering, medicine, law, and policy, contributing to patient safety and the advancement of public health.