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