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