No. 17472
Promulgation Date 2020-08-11
Ministry of Health and Welfare
ALL
CHAPTER I GENERAL PROVISIONS
Article 1 (Purpose)
Article 2 (Definitions)
Article 3 (Relationship to Other Statutes)
Article 4 (Responsibility of the State)
CHAPTER II FORMULATION OF MASTER PLANS
Article 5 (Formulation of Master Plans)
Article 6 (Formulation of Action Plans)
Article 7 (Advanced Regenerative Medicine and Advanced Biological Products Policy Review Committee)
Article 8 (Promotion of Industry and Facilitation of Research and Development)
Article 9 (Establishment and Designation of Advanced Regenerative Medicine Support Institutions)
CHAPTER III IMPLEMENTATION OF CLINICAL RESEARCH OF ADVANCED REGENERATIVE MEDICINE AND SAFETY MANAGEMENT THEREOF
Article 10 (Advanced Regenerative Medicine Implementation Institutions)
Article 11 (Consent to Clinical Research of Advanced Regenerative Medicine)
Article 12 (Deliberation on and Approval of Protocols for Clinical Research of Advanced Regenerative Medicine)
Article 13 (Advanced Regenerative Medicine and Advanced Biological Products Review Committee)
Article 14 (Operation of Review Committee)
Article 15 (Advanced Regenerative Medicine Cell Processing Establishments)
Article 16 (Recovery of Human Cells)
Article 17 (Entrustment of Cell Processing Business)
Article 18 (Matters to be Observed by Heads of Cell Processing Establishments)
Article 19 (Advanced Regenerative Medicine Safety Management Institutions)
Article 20 (Safety Monitoring and Reporting on Adverse Reactions)
Article 21 (Long-Term Follow-Up of Clinical Research of Advanced Regenerative Medicine)
Article 22 (Requests to Provide Data)
CHAPTER IV PERMISSION FOR AND SAFETY MANAGEMENT OF ADVANCED BIOLOGICAL PRODUCTS
Article 23 (Permission for Manufacturing Advanced Biological Products)
Article 24 (Manufacturing Managers of Advanced Biological Products)
Article 25 (Duty to Manage Manufacturing of Advanced Biological Products)
Article 26 (Duties of Manufacturing Advanced Biological Products, Quality Control, and Reporting)
Article 27 (Import License for Advanced Biological Products)
Article 28 (Permission of Management Business of Human Cells)
Article 29 (Matters to Be Observed by Human Cell Management Business Entities)
Article 30 (Registration of Long-Term Follow-Up, and Details of Administration, of Advanced Biological Products)
Article 31 (Labeling on Containers of Advanced Biological Products)
Article 32 (Establishment and Designation of Regulatory Science Center for Advanced Biological Products)
Article 33 (Requests to Furnish Data)
Article 34 (Guidance and Supervision over Regulatory Science Center)
Article 35 (Classification of Items to Which Advanced Biotechnology Is Applied)
Article 36 (Designation of Products Subject to Fast-Track Processing)
Article 37 (Fast-Track Processing)
Article 38 (Revocation of Designation of Products Subject to Fast-Track Processing)
CHAPTER V SUPERVISION
Article 39 (Reporting and Inspections)
Article 40 (Order for Recall and Destruction)
Article 41 (Corrective Orders)
Article 42 (Revocation of Permission and Suspension of Business)
Article 43 (Hearings)
Article 44 (Transfer of Data upon Closure of Business)
Article 45 (Penalty Surcharges Imposed in Lieu of Disposition to Suspend Business)
Article 46 (Fees)
CHAPTER Ⅵ SUPPLEMENTARY PROVISIONS
Article 47 (Delegation and Entrustment of Authority)
Article 48 (Prohibition on False or Exaggerated Advertisement)
Article 49 (Prohibition on Purchase and Sale of Human Cells)
Article 50 (Prohibition on Disclosure of Confidential Information)
Article 51 (Prohibition on Use of Similar Name)
Article 52 (Legal Fiction as Public Officials for Purposes of Applying Penalty Provisions)
Article 53 (Special Cases concerning Advanced Biological Products for Animals)
Article 54 (Succession to Status of Manufacturers)
Article 55 (Succession to Administrative Sanctions)
Article 56 (Establishment of Organizations)
CHAPTER VII PENALTY PROVISIONS
Article 57 (Penalty Provisions)
Article 58 (Penalty Provisions)
Article 59 (Penalty Provisions)
Article 60 (Penalty Provisions)
Article 61 (Concurrent Imposition of Suspension of Qualification)
Article 62 (Joint Penalty Provisions)
Article 63 (Administrative Fines)
ADDENDA <Act No. 16556, Aug. 27, 2019>
ADDENDA <Act No. 17472, Aug. 11, 2020>