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