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