Regulations

• Standards and Specifications for Utensils, Containers and Packages(No. 2020-43)
• 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)
• Standards and Specifications for Utensils, Containers and Packages(2019-2, 20190109)
• Labeling Standards of Foods, Etc.(October 28, 2019)

Regulations

• Regulation on the Registration of Active Pharmaceutical Ingredient
• Regulation for Pharmaceutical Approvals, Notifications and Reviews
• Good Laboratory Practice
• Regulation on Pharmaceutical GMP
• Regulation on Fees for Pharmaceutical Approval, etc.
• Designation of Pharmaceuticals Required to Have Pharmaceutical Equivalence
• Regulation on Approval for Investigational New Drug Application of Drugs

Regulations

• (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
• (Quasi-drugs) Guideline on Establishment of Test Item in Preparation of Standards and Analytical Methods of Quasi-Drugs

Regulations

• Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19
• Guideline on Review and Approval of Digital Therapeutics (For Industry)
• 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