2023 年 60 巻 5 号 p. 264-269
In the face of the novel coronavirus infection (COVID-19), researchers and medical professionals worldwide have been tackling to develop new drug products, and regulatory authorities also have accelerated their efforts to create new schemes for the fast-track approval of drug products. This article outlines the approval systems including the newly established emergency approval system and describes the trends in the development of COVID-19 drug products and vaccines in Japan.