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