In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a ERY Drug Master File in Korea (ERY KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ERY. The MFDS reviews the ERY KDMF as part of the drug registration process and uses the information provided in the ERY KDMF to evaluate the safety and efficacy of the drug.
After submitting a ERY 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 ERY API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ERY suppliers with KDMF on PharmaCompass.