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