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