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