Regulations

• 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
• Food and livestock products Safety Management Certification Standard(HACCP) [MFDS notice 2020-15]
• Labeling Standards for Genetically Modified Foods(No. 2019-98, October 28, 2019)

Regulations

• 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
• Regulation on Fees for Pharmaceutical Approval, etc.
• Regulation on Approval for Investigational New Drug Application of Drugs.

Regulations

• 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
• (Quasi-drugs) Guideline to Efficacy Evaluation of Mosquito Repellent
• (Quasi-drugs) Evaluation Guideline for Sterile Quasi-Drugs

Regulations

• Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19
• Guideline on Review and Approval of Artificial Intelligence(AI) and big data-based Medical Devices (For Industry)
• Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry)
• Act on In Vitro Diagnostic Medical Devices
• Brochure for Korean Medical Device(English Version)
• Guidance on Patient-matched Medical Devices manufactured using 3D printers
• Medical Device Standards and Specifications