The Ministry of Food and Drug Safety (MFDS) has published the 2024 National Lot Release Annual Report to transparently disclose the status of national lot release for biological products and to promote the excellence of Korea’s quality control system for biologics. The main contents of the ...

The Ministry of Food and Drug Safety (MFDS) has published the 2023 National Lot Release Annual Report to transparently disclose the status of national lot release for biological products and to promote the excellence of Korea’s quality control system for biologics. ...

The Ministry of Food and Drug Safety (MFDS) has published the 2022 National Lot Release Annual Report to transparently disclose the status of national lot release for biological products and to promote the excellence of Korea’s quality control system for biologics. The main contents of the ...

The Ministry of Food and Drug Safety (MFDS) has published the 2021 National Lot Release Annual Report to transparently disclose the status of national lot release for biological products and to promote the excellence of Korea’s quality control system for biologics. The main contents of the ...

The Ministry of Food and Drug Safety (MFDS) has published the 2020 National Lot Release Annual Report to transparently disclose the status of national lot release for biological products and to promote the excellence of Korea’s quality control system for biologics. The main contents of the ...

Guideline on Establishment of Chemical Profilesfor Herbal Medicinal Products (English version)

(Biological Products) Biosimilar Product Evaluation Guideline

Specifications and Test Methods for Biologicals(MFDS Notification, No.2022-58)

Rule on the Safety of Human Tissue(Jul.12,2022)

Manufacturing and Marketing Control Rules for Biologics， etc. (Ordinance of the Prime Minister No. 1717, Jul. 16, 2021)