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