Korea to Restart International Drug Inspection in 2023

International KGMP biopharmaceutical inspections were halted in Korea in early 2021 because of the COVID-19 pandemic. However, in September, the Ministry of Food and Drug Safety (MFDS) announced that they will proceed with these KGMP inspections in 2023. Since there is now a backlog of inspections, the MFDS will focus on new drugs and their facilities that have not been inspected before. Also, drug factories that failed inspections before will now face greater scrutiny. For overseas factories that produce urgently needed or orphan drugs, remote inspections will still be possible. Normally, the MFDS will send 2-3 GMP inspectors to each site for audits.