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