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