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