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