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