In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a alpha-Tocopherol acetate, European Pharmacopoeia (EP) Reference Standard Drug Master File in Korea (alpha-Tocopherol acetate, European Pharmacopoeia (EP) Reference Standard KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of alpha-Tocopherol acetate, European Pharmacopoeia (EP) Reference Standard. The MFDS reviews the alpha-Tocopherol acetate, European Pharmacopoeia (EP) Reference Standard KDMF as part of the drug registration process and uses the information provided in the alpha-Tocopherol acetate, European Pharmacopoeia (EP) Reference Standard KDMF to evaluate the safety and efficacy of the drug.
After submitting a alpha-Tocopherol acetate, European Pharmacopoeia (EP) Reference Standard 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 alpha-Tocopherol acetate, European Pharmacopoeia (EP) Reference Standard API can apply through the Korea Drug Master File (KDMF).
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