In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a EFZ Drug Master File in Korea (EFZ KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of EFZ. The MFDS reviews the EFZ KDMF as part of the drug registration process and uses the information provided in the EFZ KDMF to evaluate the safety and efficacy of the drug.
After submitting a EFZ KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their EFZ API can apply through the Korea Drug Master File (KDMF).
click here to find a list of EFZ suppliers with KDMF on PharmaCompass.