Abstract
Drug delivery systems (DDS) can provide new, important technologies that lead to more effective and safer treatments while having improved cost-effectiveness, and have been expected to drive the innovation of business models of the pharmaceutical industry. Continual development of effective DDS preparations by pharmaceutical companies is necessary, given that the technologies will inevitably become dominant issues in the field of medicinal treatment as well as being essential for the growth of the pharmaceutical industry. Therefore, implementation of regulatory structures and creation of an environment that will activate the development of DDS preparations by pharmaceutical companies are required. We then discuss how important issues relating to the development of DDS preparations should be improved from the points of view of regulatory science and pharmacoeconomics in this manuscript.