Current status and issues of drug development strategy in Japan

Serious stagnation and low productivity in new drug discovery and development have been raised an alarm how the pharmaceutical industry can explore appropriate drug candidates and conduct efficient development as well as preventing drop-out at the later clinical stage. For this purpose, we must reconsider several empirical and stereotypical programs so far used in clinical development. Instead, the human based exploratory clinical study such as single micro dosing PK study campaigned by both US and European regulatory agencies might be one of powerful tools to ascertain the possibility "to go" or "not to go" at the earlier stage of drug development. In order to improve traditionally insufficient subject enrollments only in domestic clinical trials, participation in multinational clinical trials will make possible an adequate evaluation of drug safety and efficacy through systematic comparison with foreign data. Further efforts should be paid to establish an infrastructure and circumstance to achieve this kind of clinical trials in Japan soon. We should also learn about how to manage the provisions of Japan own by referring not only clinically forward US and European countries but also Asian. The ICH E2E-guided proactive post-marketing surveillances and clinical trials after approval might be important for understanding the details without consuming too much time as well as money at the R&D stages.