Due to the COVID-19 pandemic several years ago, the Korean Ministry of Food and Drug Safety (MFDS) stopped its on-site inspections of drug maker’s foreign manufacturing plants. In March 2022 however, the Ministry announced that it was going to resume in-person inspections from April to November this year. Around 50 out of 2,208 overseas manufacturing sites will be inspected next month. If the on-site inspections are difficult due to the further spread of the pandemic, the Ministry will resort to virtual inspections and document reviews. The Ministry may request supplementary documentation if they deem the initial submission insufficient. Failure to supplement additional information may lead to penalties such as the suspension of drug imports.
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.
Source used in the article: https://www.koreabiomed.com/news/articleView.html?idxno=14658