Connecting people, advancing clinical value
Connecting people, advancing clinical value
In 2025, the Korean MFDS approved 126 new Medical Device Clinical Trials, driven by a surge in digital health innovations and diverse therapeutic devices. This year-end analysis summarizes the Clinical Trials approvals, highlighting monthly trends, regulatory context, key sponsor activities,…
Overview In December 2025, the Ministry of Food and Drug Safety (MFDS) approved eight Medical Device Clinical Trial applications, marking a busy end to the year. These MFDS approvals for Medical Device Clinical Trial proposals spanned a diverse range of…
Overview In 2025, the Korean Ministry of Food and Drug Safety (MFDS) granted 636 Investigational New Drug (IND) approvals, reflecting sustained high Clinical Trials activity. Monthly approvals fluctuated from a peak of 82 IND approvals in January to a low…
Introduction South Korea’s Ministry of Food and Drug Safety (MFDS) approved a total of 45 new clinical trials in December 2025, capping the year with a significant uptick in regulatory greenlights for Investigational New Drug (IND) applications. This robust monthly…