MFDS - Regulations ( PDFs)
Download copies of 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
Regulation on Fees for Pharmaceutical Approval, etc.
Regulation on Approval for Investigational New Drug Application of Drugs.
Regulation on Safety of Pharmaceuticals, etc.
Standard Manufacturing Criteria for Drugs.
Standard on Pharmaceutical Equivalence Study.
Regulation for Pharmaceutical Approvals, Notifications and Reviews
Standard for Toxicity Study of Pharmaceuticals
Regulation on Recall of Pharmaceuticals
Enforcement Regulation of the Enforcement Decree on the Standards of Facilities of Manufacturers and Importers of Medicinal Products,etc.
Enforcement Decree on the Standards of Facilities of Manufacturers and Importers of Medicinal Products, etc.
Standard for Re-examination of New Drugs
Regulation on the Renewal of Drug Products
Regulation on the Registration of Active Pharmaceutical Ingredient
Guidelines for Recommending Drugs and Cosmetics for Exemption from Import Requirements
Regulation for Supplying Medicinal Products in a Small Package Unit
Regulation on the Execution of Re-Evaluation of Pharmaceuticals
Regulation on Preliminary Examination Operation on Medical Products.
Regulation on Registration of Overseas Manufacturing Factories for Drugs, etc.
ENFORCEMENT DECREE OF THE NARCOTICS CONTROL ACT (30545)
NARCOTICS CONTROL ACT (17091)
ENFORCEMENT DECREE OF THE PHARMACEUTICAL AFFAIRS ACT(30170)
Pharmaceutical Affairs Act
Quality Considerations for Microneedling Products (Guideline for Industry)
Regulation on Safe Containers, Packaging, and Dosing Dispensers for Pharmaceuticals
Designation of Pharmaceuticals Required Securing Pharmaceutical Equivalence
Regulation on Management of Imported Drugs and Quasi-drugs
Regulation on Stability Test of Pharmaceuticals
Regulation on the Labeling of Medicinal Products, etc.
Regulation on Codes for Classification of Drugs and Other Products
Good Laboratory Practice
Regulation on Pharmaceutical GMP
Certificate of Qualified Company of Good Supplying Practice for Medicinal Products
Designation, Specification and Test Method of Tar Colors in Pharmaceuticals, etc.
Regulation on Designation of Orphan Drugs
Korean Pharmacopoeia (Tenth Edition)
Enforcement Decree of The Narcotics Control Act
Narcotics Control Act
Regulation on Pharmacology Study for Pharmaceuticals, etc.
Guideline on Assessment for Off-Label Drugs
Guidance on Phase I Clinical Trial in Healthy Subjects