企業における海外開発の日本誘致に関する取り組み

抄録

In recent years, the challenges surrounding access to medicines in Japan have undergone a qualitative shift. With the acceleration of regulatory review by the Pharmaceuticals and Medical Devices Agency (PMDA) and the promotion of multinational clinical trials, the long–standing issue of “drug lag”―the delay in the availability of new medicines in Japan compared with other countries―has been substantially alleviated. In contrast, a new societal challenge known as “drug loss,” in which medicines approved overseas are neither developed nor approved in Japan, has emerged. This issue is particularly pronounced in the fields of neurology and psychiatry, where a high proportion of innovative therapies that are considered standard of care abroad remain unavailable in Japan, resulting in growing concerns about patients being unable to access necessary treatments. This paper outlines the current status and underlying factors of drug lag and drug loss in Japan, introduces the initiatives of Aculys Pharma Inc., a company dedicated to bridging overseas pharmaceutical innovation into the Japanese market, and discusses future institutional challenges and perspectives for improving equitable access to innovative medicines.