Abstract
To solve the issue of the unapproved drugs and off-label drugs, since 2005, several approaches had been tried like the establishment of “Usage of Unapproved Drugs Review Conference”, “pediatric drug therapy Review Conference”, “Conference for suitable clinical trials” and “Conference for rapid delivery of the effective and safe medicines”. With these activities, we can have solved the unapproved drugs and off-labeled drugs in some degree. But the effect was restricted in the end because there were short of the financial support. In order to eliminate the lack of incentives for pharmaceutical companies, in 2009 fiscal corrective budget “support project for developing the unapproved drugs” was established as the fund for 3 years. And the new subsequent supportive drug pricing policy “incentive for acceleration to develop new drugs and off-label drugs” are now available as a trial schema from 2009 fiscal. Owing to the new these incentives, unapproved drugs and off-label drugs have been rapidly reduced and drug-lag are almost resolved now. But we are planning to improve the current system into more effective manner. As the further efforts, we are planning to establish “unapproved drugs rapid commercialization scheme”, and “expand access schema” in 2015.
