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