Abstract
The success rate has decreased to 1/30,000 or less while the cost of the new medicine development increases in recent years. To improve this situation, Pharmaceuticals and Medical Devices Agency (PMDA) has been executing Pharmaceutical Affairs Consultation on R&D Strategy since July, 2011. The personnel exchange has been begun by the budget of Ministry of Health, Labour and Welfare (MHLW) between PMDA and research laboratories since October, 2012. On the other hand, United States Food and Drug Administration (FDA) commissioner published "The Path to Personalized Medicine" in July, 2010 on the New England Journal of Medicine. Subsequently, FDA has been publishing various reports to support the practical use of innovative new drugs as regulatory authority. As for this approach of a regulator each Japan-U.S., a strategy, a personnel training, and an open innovation necessary for the innovative DDS development are expected to be promoted rapidly.
