Regulations

• Food Additives Code(#2023-60, 2023.9.20.)
• PLS Leafelt(regarding Veterinary drugs residues in food)
• Food Code (No.2021-54, 2021.6.29.)
• Food Additives Code(#2021-19, 2021.03.09.)
• Standards and Specifications for Utensils, Containers and Packages(No. 2021-76)
• Food Additives Code(#2020-59, 2020.07.10.)
• Korean version of Canada's Food safety preventive control plan checklist

Regulations

• Enforcement Rule of the Regulations on Relief of Injury from Side Effects of Drugs(No. 1783)
• The Enforcement Rule of the Narcotics Control Act (No. 1781)
• Regulations on the Criteria for Classification of Drugs(MFDS Notification No.2019-55, July 1, 2019)
• Designation of Drugs Not Eligible for Allowances for Relief of Injury from Adverse Drug Reaction(MFDS Notification, No.2017-62, 25 July 2017)
• Guideline on Re-Examination Affairs of New Drug,etc.
• Regulation on the Labeling of Medicinal Products,etc.
• Regulation on Good Manufacturing Practices (GMP) for Medicinal Products

Regulations

• 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)
• (Advanced Biopharmaceutical Products) Guideline on Quality Assessment for Gene-editing Based Advanced Therapy Medicinal Products
• (Advanced Biopharmaceutical Products) Guideline on Nonclinical Assessment for Gene Therapy Products
• (Quasi-drugs) Guideline for Measurement Method of Harmful Ingredients in Cigarette-type Smoking Craving Suppressant
• (Quasi-drugs) Guideline to Efficacy Test Method of Mite Repellent

Regulations

• Instructions on Labeling and Management of Unique Device Identifiers
• Regulations on Labeling and Description of Medical Devices
• Standards of Medical Device Good Manufacturing Practices_Revised
• Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices
• Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices
• Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19
• Guidance on the Review and Approval of Digital Therapeutics(DTx)(Revision)