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