Technical Report Promotion of Medical R&D in Japan under Abenomics

ITO, Yuko  ,  NAGANO, Hiroshi

16-112016-08 , GRIPS Policy Research Center
Japan’s cabinet has been pushing forward with economic policy knowns as Abenomics since December 26 in 2012. Abenomics also includes the promotion of R&D in the medical field and related legislative reforms. The Headquarters for Healthcare and Medical Strategy Promotion was established in the cabinet in 2013. In 2014, “Act to Promote Healthcare and Medical Strategy” was promulgated and included for the formulation of the Health and Medical Strategy, the creation of the Plan for Promotion of medical R&D by the Headquarters, and the newly establishment for Japan Agency for Medical Research and Development. In 2014 the Pharmaceutical Affairs Law was revised and it newly contains the strengthening of safety measures for pharmaceuticals and medical devices, the construction of regulations taking into account the characteristics of medical devices, and a new definition for regenerative medicine along with approvals for manufacturing and sales in light of its special characteristics. Further, “Sakigake Package Strategy” formulated in 2014, which included an “advanced review designation system” as a fast-track- applications. With only three years having passed since the implementation of the policies related to Abenomics in 2013, it may be premature to judge their outcome, but several positive signs are appearing.

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