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