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