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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.