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