Regulations

• Standards and Specifications for Utensils, Containers and Packages(No. 2024-29)
• Standards and Specifications for Utensils, Containers and Packages(No. 2022-97)
• 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)

• Food Safety
• Imported Food Safety
• Promoting Healthy Diets and Safe Food Consumption
• Food Labeling System
• Regulations
• Products
• Food Certificate Verification

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.

• Approval Process
• Regulations
• Products
• Drugs Certificate Verification
• Guideline
• Global Innovative products on Fast Track(GIFT)
• Global Harmonization Center(GHC)

Regulations

• 2024 Annal Report of National Lot Release
• 2023 Annual Report of National Lot Release
• 2022 Annual Report of National Lot Release
• 2021 National Lot Release Annual Report
• 2020 Annual Report of National Lot Release
• Guideline on Establishment of Chemical Profiles for Herbal Medicinal Products (English version)
• (Biological Products) Biosimilar Product Evaluation Guideline

• Approval Process
• Regulations
• Manufactures
• Biosimilar
• Bio&Quasi-drugs Certificate Verification

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

• Approval Process
• Regulations
• Products
• Medical Devices Certificate Verification
• Innovative Medical Devices Designation