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