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