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