ABSTRACT
To understand the policy, institutional, and organizational changes that have been made and to determine whether they closed the “device lag” and improved regulatory capacities and processes, this chapter focuses on government plans and strategies to address the underdeveloped stage of access to advanced medical therapies. Current and future progress hinges on two poles: medical practice and clinical skills, and innovative and novel medical devices of the domestic industry. The chapter is divided into several parts. The first part begins with a brief discussion to show how a “device lag” in Japan is interdependent with medical practice and a lack of standardized medical procedures in specialty medicine. The second part explores a range of policy and administrative initiatives and activities undertaken jointly by three ministries—MHLW, METI, and MEXT. The aim is to promote innovation creation, close the “device lag” in Japan, and overcome the multiple obstacles to speedy implementation and desired outcomes. A final part clarifies whether the politics or policy initiatives explain ongoing administrative activities.
