Abstract
Regulatory science plays an important role to implement scientific approach for evaluating the benefit and the risk of medical products. That approach is important to obtain consensus from various stakeholders even at any steps of developmental, approval, or marketing step. Comprehensive study fields, ranging from basic to social science, must be dealt with, and rapid technological progress needs to be kept up with. Hence, it is strongly demanded to advance regulatory science through research and to cultivate human resources through education. In this article, we report up-to-date status of the research and education in EU and US regarding regulatory science. In US, the most noticeable change was the expansion of the Center of Excellence in Regulatory Science and Innovation (CERSI) to the west coast in 2014. This expansion is made because many venture companies of biotechnology and of information and communication technology are located there. This represents that Food and Drug Administration (FDA) is aware that those companies are next key players in the medical fields. In EU, European Medicines Agency (EMA), acts differently from FDA ; i. e. financial support is strictly excluded, although EMA does participate in collaborative research activities. Instead, EMA puts the strong emphasis on the educational training to equalize the regulatory levels among EU countries in terms of the quality, safety, and efficacy of medical products. It was uniqueness that appeared from our inquiry about how the two biggest regulatory bodies in the world promoted research and education of regulatory science. It is our expectation to learn from their examples so that we also pursue unique, but globally compatible, Japanese-way of promoting regulatory science.
