In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 3prs Drug Master File in Korea (3prs KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 3prs. The MFDS reviews the 3prs KDMF as part of the drug registration process and uses the information provided in the 3prs KDMF to evaluate the safety and efficacy of the drug.
After submitting a 3prs 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 3prs API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 3prs suppliers with KDMF on PharmaCompass.