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