So far, drug contribution has been low for the treatment of diseases in the central nervous system (CNS). This is partly because drug delivery system(DDS)which can migrate across the blood-brain barrier has not been successfully developed, and it has been difficult to develop new drugs for CNS diseases. Although some developing drugs have progressed to phase II or III in clinical trials, they are not always successful. However, some of the approved drugs for the CNS diseases have been effective when directly administered by highly invasive methods into the CNS, such as the medullary cavity. In this paper, we describe the expectation for the latest DDS technology from the viewpoint of the Pharmaceuticals and Medical Devices Agency, based on the background that there are needs to improve the situation.