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