2023 年 40 巻 4 号 p. 421-424
With the COVID–19 pandemic starting in 2020, digitization is accelerating worldwide, and the trend is reaching the medical community. Various new technologies have been introduced into methodologies of new medical technology development, which has expanded at a rapid pace. In Japan, while delays in responding to digitalization have become apparent, particularly in the medical and administrative sectors, rapid changes have also begun to take place that incorporate the new trends. Japan's regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), has also been taking various actions in response to the COVID–19 pandemic and the rapid changes that followed. This paper introduces the PMDA's work and recent initiatives, including utilization of real world data, international activities, and promoting patient and public involvement.
