1. Executive Summary

This workbook provides an overview of the current and proposed regulatory landscape applicable in South Korea in relation to Decentralized Clinical Trials (“DCTs”). Clinical Trials are governed in Korea by the Ministry of Food and Drug Safety (MFDS), with additional oversight provided at an institutional level by Independent Review Boards (IRBs).

South Korea is limited in the adoption of telehealth due to the current regulations. However, it is generally an early adopter of technology. Telehealth was used under emergency powers during the COVID-19 pandemic and is expected to continue. DCTs have not yet been conducted in Korea. However, elements of decentralization are being adopted and the regulations in Korea are expected to continue to evolve toward the decentralized model in the coming years.