MFDS Survey Flags Issues at Five Korean Clinical Trial Sites

The Food and Drug Safety Ministry (MFDS) has published the results of its regular inspection of institutions that conduct drug clinical trials. The survey identified compliance issues that require corrective action at five facilities: Kyung Hee University Hospital, Joheung Kang‑an Hospital, Dankook University Dental College Hospital, Daegu Hanui Daehanbang Hospital, and Hallym University Han River Seongshim Hospital. In contrast, the Korea University College of Medicine Affiliated Hospital was found to have no identified issues. The inspection was carried out in accordance with Article 34 of the Pharmaceutical Affairs Act and related regulations, aiming to verify adherence to Good Clinical Practice (GCP) and fulfillment of designated requirements. On‑site visits were conducted at each institution as part of the assessment process.