The Korean Ministry of Food and Drug Safety (MFDS) has made a major overhaul to its disclosure policies regarding Good Manufacturing Practice (GMP) inspection outcomes. The MFDS will now disclose results in full, instead of in the past, just issuing heavily redacted reports at the request of drug companies.
According to the new policy, the only information that can be withheld is a trade or business secret. Any drug company’s request for its inspection outcome to be kept confidential will now be heavily scrutinized. Inspection results will now be broken down into “Serious”, “Important”, or “Other” categories. There is a clear distinction between whether an infraction leads to a serious administrative action or only requires supplemental measures. The report will also outline whether corrective actions were completed and approved.
Only the Korean inspector’s institution and department will be revealed for GMP inspections, not the personal names of the inspectors. This practice prevents companies from customizing their responses to each individual inspector. All inspection targets will be standardized for finished products by dosage form and for APIs by a manufacturing process, to be consistent with GMP compliance certificates.
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.