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