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