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