Abstract
At the same time that drug development is becoming more global, the discovery process has become more protracted and therefore more costly. To efficiently produce effective and innovative drugs, we have to promote education and research in regulatory science. As the largest drug market, as well as the springboard for new drug creation, we investigated the state of education and research in regulatory science in the United States (US). The results indicated that the regulatory bodies both in the US, Food and Drug Administration, and Japan initiated changes in regulatory science. Moreover each university provided its own distinctive education and research in this area. Three key issues surfaced in our analysis: 1) optimization of specialized education using alternative delivery methods including full-time on-line educational programs, 2) communication in educational settings as the means of transmitting critical information between industry-government-academia, and 3) seamless cooperation of universities and/or industry-government-academia. The education and research in regulatory science in pharmaceutics has just started in Japan. The dynamic cooperation among industry-government-academia in this area is rare. Pharmaceutics in integrated academic areas such as pharmacokinetics, drug formulation and analytical chemistry, should play an important role for expanding regulatory science. We aim to accelerate drug development within Japanese industry and regulatory bodies by expanding Japanese education and research in regulatory science by utilizing some of the US approaches.
