53 Active Substance Categories Subject to On-Site Inspections Prior to DMF Approval

Reflective of the government's effort to officially implement the Pharmaceutical Bulk Report System scheduled by September of this year, the Korea Food and Drug Administration (KFDA) said it has selected 107 manufacturers with DMF (Drug Master File) submissions that are subject to the pre-approval inspections.

Consisting of 27 domestic and 80 overseas locations, these manufacturers collectiv...