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