Government policies for creation of world-leading innovative new drugs from Japan

Abstract

The government has been taking various measures for the development of innovative drugs and the growth of pharmaceutical industry, based on "The 5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices" set in 2007. As a new measure to promote clinical studies, the Ministry of Health, Labour and Welfare(MHLW)will create infrastructure for early-stage and exploratory clinical trials in Japan next fiscal year. Moreover, in order to assess innovations appropriately, MHLW introduced a new scheme on a trial basis in the 2010 drug price revision, where the price reduction of new drugs meeting certain requirements is transiently mitigated until a generic product is marketed, expecting that this will promote the new drug development. The government will continue to advance unified approaches among industry, academia and government, based on "The New Growth Strategy" decided by the Cabinet in June 2010. © 2011 Japan Society of Drug Delivery System.