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