Regulations

• Regulation on Recognition of Functional Ingredient and of Standard·Specification for Health Functional Foods (No. 2021-66)
• Standards for Recognition of Temporary Standards and Specifications for Foods (No. 2024-13)
• ENFORCEMENT DECREE OF THE FOOD SANITATION ACT
• FOOD SANITATION ACT
• Labeling Standards of Foods, Etc (No. 2022-66)
• Standard of Unfair Labeling or Advertising Content of Foods (No. 2021-89)
• Registration and Control Standards of Good Importers (No. 2022-92)

Regulations

• Korean Pharmacopoeia (Twelfth Edition)
• 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.

Regulations

• Guideline on Establishment of Chemical Profiles for 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)
• (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

Regulations

• Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs
• Regulations on Unique Device Identification Management, Etc.
• Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices
• Enforcement Rule of the Medical Devices Act
• Regulation on the Permission, Notification, Review, Etc. of Medical Devices
• Enforcement Rule of the Act on In-Vitro Diagnostic Medical Devices
• Instructions on Labeling and Management of Unique Device Identifiers