In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus Drug Master File in Korea (RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus. The MFDS reviews the RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus KDMF as part of the drug registration process and uses the information provided in the RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus KDMF to evaluate the safety and efficacy of the drug.
After submitting a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus 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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus API can apply through the Korea Drug Master File (KDMF).
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