The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) published and distributed the ‘Clinical trial guideline on antiviral treatments for mild-to-moderate COVID-19 infections’ to support the rapid development of COVID-19 antivirals by guiding companies on the new clinical outcome parameters and methods for designing flexible clinical trials.

The guideline was prepared to promote the preparation of a rapid clinical support platform to support the development of COVID-19 vaccines and treatments, which was part of the 100 Tasks for Food and Drug Regulatory Innovation that the MFDS had announced on August 11th.

The guideline contains the additional new clinical outcome parameters