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