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