In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a AB1 Drug Master File in Korea (AB1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AB1. The MFDS reviews the AB1 KDMF as part of the drug registration process and uses the information provided in the AB1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AB1 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 AB1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AB1 suppliers with KDMF on PharmaCompass.