ENFORCEMENT DECREE OF THE ACT ON THE SAFETY OF AND SUPPORT FOR ADVANCED REGENERATIVE MEDICINE AND ADVANCED BIOLOGICAL PRODUCTS
Presidential Decree No. 30979, Aug. 27, 2020
Amended by Presidential Decree No. 32268, Dec. 28, 2021
Presidential Decree No. 33112, Dec. 20, 2022
Presidential Decree No. 33435, Apr. 27, 2023
Presidential Decree No. 33671, Aug. 16, 2023
CHAPTER I GENERAL PROVISIONS
| Article 2 (Scope of Advanced Regenerative Medicine) |
| 1. | Cell therapy: Treatment on humans by using cells derived from humans or animals; |
| 2. | Gene therapy: Treatment by transferring genetic material into the human body or transferring into the human body the cells of humans or animals in which genetic material is transformed or implanted; |
| 3. | Tissue engineering therapy: Treatment on humans by applying an engineering technology to cells or tissues derived from humans or animals for the purpose of regeneration, restoration, or replacement, etc. of tissues; |
| 4. | Convergence therapy: Treatment that falls under any of the following subparagraphs: |
| (a) | A medical treatment that mixes at least two of the medical treatments specified in subparagraphs 1 through 3; |
| (b) | A medical treatment that combines a medical treatment referred to in any of subparagraphs 1 through 3 and item (a) of this subparagraph and medical devices specified in Article 2 (1) of the Medical Devices Act in physical and chemical manners (including convergence, combination, etc.). |
| (2) | "Those prescribed by Presidential Decree" in the proviso of subparagraph 1 of Article 2 of the Act means any of the following procedures: |
| 2. | Other procedures publicly notified by the Minister of Health and Welfare, following deliberation by the Advanced Regenerative Medicine and Advanced Biological Products Policy Review Committee established under Article 7 (1) of the Act (hereinafter referred to as the "Policy Committee"). |
| Article 3 (Scope of Human Body Cells) |
“Human cells, tissues, or organs prescribed by Presidential Decree, such as stem cells, hematopoietic stem cells, somatic cells, immunocytes, and xenogenic cells, which are derived from human bodies” in the main clause of subparagraph 2 of Article 2 of the Act means those falling under any of the following subparagraphs: | 1. | Cells and tissues derived from humans or animals, or those treated in physical, chemical, and biological manners, such as fabrication, processing, and production; |
| 2. | Organs of animals or those treated in physical, chemical, or biological manners, such as fabrication, processing, and production; |
| 3. | Others utilizing cells, tissues, organs, etc. specified in subparagraph 1 or 2, which are publicly notified by the Minister of Health and Welfare in consultation with the Minister of Food and Drug Safety, following deliberation by the Advanced Regenerative Medicine and Advanced Biological Products Review Committee under Article 13 (1) of the Act (hereinafter referred to as the "Review Committee"). |
| Article 4 (Classification of Degree of Risk of Clinical Research on Advanced Regenerative Medicine) |
"A research ... prescribed by Presidential Decree" in the provisions, with the exception of the items, of subparagraph 3 of Article 2 of the Act means the research categorized as follows: | (a) | Research using embryonic stem cells and induced pluripotent stem cells; |
| (b) | Research using cells derived from animals; |
| (c) | Research using cells derived from other persons (excluding embryonic stem cells and induced pluripotent stem cells): Provided, That cases where cells are used with minimal manipulation, such as simple separation, cleaning, freezing and thawing (hereafter referred to as "minimal manipulation” in this Article) shall be excluded; |
| (d) | Research using genes; |
| (e) | Research using artificial tissues or organs aimed at a complete replacement of body functions; |
| (a) | Research using cells that are derived from the human subject of research (excluding embryonic stem cells and induced pluripotent stem cells): Provided, That cases where cells are used with minimal manipulation shall be excluded; |
| (b) | Research using cells derived from other persons (excluding embryonic stem cells and induced pluripotent stem cells) after minimally manipulating them; |
| (c) | Research using artificial tissues or organs aimed at structural restoration of body functions; |
| (a) | Research using cells derived from the human subject of research (excluding embryonic stem cells and induced pluripotent stem cells) after minimally manipulating them; |
| (b) | Research specified in any item of subparagraph 2, which has been proved for its safety based on sufficient accumulation of research data, etc. and publicly notified by the Minister of Health and Welfare following deliberation by the Review Committee. |
CHAPTER II FORMULATION OF MASTER PLANS
| Article 5 (Scope of Heads of Relevant Central Administrative Agencies) |
"The heads of the relevant central administrative agencies prescribed by Presidential Decree" in Article 5 (3) of the Act means the heads of the following institutions: | 1. | The Ministry of Economy and Finance; |
| 2. | The Ministry of Education; |
| 3. | The Ministry of Science and ICT; |
| 4. | The Ministry of Agriculture, Food and Rural Affairs; |
| 5. | The Ministry of Trade, Industry and Energy; |
| 6. | The Ministry of Oceans and Fisheries; |
| 7. | The Ministry of SMEs and Startups. |
| Article 6 (Notification of Guidelines on Formulation of Master Plans) |
| (1) | The Minister of Health and Welfare shall prepare the guidelines on formulation of a master plan for advanced regenerative medicine and advanced biological products referred to in Article 5 (1) of the Act (hereinafter referred to as "master plan") by May 31 of the year immediately preceding the year in which the master plan is implemented, and shall notify the Minister of Food and Drug Safety and the heads of relevant central administrative agencies referred to in Article 5 thereof (hereinafter referred to as the "heads of the relevant central administrative agencies"). |
| (2) | The Minister of Food and Drug Safety and the heads of the relevant central administrative agencies shall prepare policy measures, etc. for the sector under their jurisdiction regarding the matters specified in the subparagraphs of Article 5 (2) of the Act in accordance with the guidelines on formulation of a master plan referred to in paragraph (1), and shall submit such policy measures, etc. to the Minister of Health and Welfare by August 31 of the year immediately preceding the year in which the master plan is implemented. |
| Article 7 (Formulation of Action Plans) |
| (1) | The Minister of Food and Drug Safety and the heads of the relevant central administrative agencies shall submit action plans for support and management of advanced regenerative medicine and advanced biological products prescribed in Article 6 (1) of the Act (hereinafter referred to as "action plans") to the Minister of Health and Welfare by October 31 of the year immediately preceding the year in which action plans are implemented pursuant to paragraph (2) of that Article. |
| (2) | The Minister of Health and Welfare shall compile and review action plans submitted pursuant to paragraph (1), and formulate an action plan following deliberation by the Policy Committee. |
| (3) | The Minister of Health and Welfare shall notify the Minister of Food and Drug Safety and the heads of the relevant central administrative agencies of an action plan formulated under paragraph (2) without delay. |
| Article 8 (Composition of Policy Committee) |
| (1) | The term of office of each member of the Policy Committee commissioned under Article 7 (3) of the Act shall be two years. |
| (2) | The chairperson of the Policy Committee may dismiss its member prescribed in paragraph (1) in any of the following cases: |
| 1. | Where he or she becomes incapable of performing his or her duties due to mental or physical disability; |
| 2. | Where he or she engages in any misconduct in relation to his or her duties; |
| 3. | Where he or she is deemed unsuitable for the position due to neglect of duties, injury to dignity, or any other reasons; |
| 5. | Where he or she voluntarily declares that it is impracticable to perform his or her duties. |
| Article 9 (Operation of Policy Committee) |
| (1) | The chairperson of the Policy Committee shall represent the Policy Committee and exercise general control over the affairs thereof. |
| (2) | If the chairperson of the Policy Committee is unable to perform his or her duties due to unavoidable causes, a member designated in advance by the chairperson shall act on behalf of the chairperson. |
| (3) | Where requested by at least 1/3 of all incumbent members of the Policy Committee or where deemed necessary by the chairperson of the Policy Committee, the chairperson of the Policy Committee shall convene and preside over its meetings. |
| (4) | A majority of the members of the Policy Committee shall constitute a quorum, and any decision thereof shall require the concurring vote of a majority of those present. |
| (5) | Where a member prescribed in Article 8 (1) attends the meetings of the Policy Committee, he or she may be paid allowances, travel expenses and other necessary expenses within budgetary limits. |
| (6) | Except as provided in paragraphs (1) through (5), details necessary for the operation of the Policy Committee shall be determined by the chairperson through a resolution by the Policy Committee. |
CHAPTER III PRACTICE AND SAFETY MANAGEMENT OF CLINICAL RESEARCH ON ADVANCED REGENERATIVE MEDICINE
| Article 10 (Good Practices for Conducting Clinical Research on Advanced Regenerative Medicine) |
The good practices for conducting clinical research on advanced regenerative medicine under Article 10 (4) of the Act shall be as follows: | 1. | Researchers shall comply with an action plan for clinical research on advanced regenerative medicine of which appropriateness is notified or approved under Article 12 (2) and (3) of the Act; |
| 2. | Researchers shall prepare, and comply with, a response manual in the event of any adverse reaction; |
| 3. | Researchers shall regularly check the progress of clinical research on advanced regenerative medicine and the health condition of each human subject of research, to explain the details of the progress and condition to each subject of research; |
| 4. | Researchers shall comply with other standards publicly notified by the Minister of Health and Welfare as deemed necessary for clinical research on advanced regenerative medicine. |
| Article 11 (Submission of Research Protocol for Advanced Regenerative Medicine) |
| (1) | Where a person designated as an advanced regenerative medical institution pursuant to Article 10 (1) of the Act (hereinafter referred to as "regenerative medical institution") intends to conduct clinical research on advanced regenerative medicine pursuant to Article 12 (1) of the Act, the person shall prepare an application in the Form prescribed by Ordinance of the Ministry of Health and Welfare by attaching a protocol for clinical research on advanced generative medicine prescribed in that paragraph (hereinafter referred to as a "research protocol for advanced regenerative medicine”) and submit it to the Review Committee. In such cases, a research protocol for advanced regenerative medicine shall include the following: |
| 1. | Objectives of clinical research on advanced regenerative medicine and the period for practice thereof; |
| 2. | Self-classification of the degree of risk of clinical research on advanced regenerative medicine referred to in Article 4 and grounds for the safety and effectiveness of clinical research on advanced regenerative medicine; |
| 3. | Types of human cells, etc. used for clinical research on advanced regenerative medicine and the procedures and methods of recovery, inspection, treatment, and storage thereof; |
| 4. | Methods of conducting clinical research on advanced regenerative medicine, such as methods, route, and cycles of injection of human cells, etc.; |
| 6. | Criteria for the selection of human subjects of research and the number of human subjects; |
| 7. | Safety management measures for human subjects of research, such as a response manual in the event of any adverse reaction; |
| 8. | Compensation measures for human subjects of research in cases of any accident arising from their participation in clinical research on advanced regenerative medicine, and relevant rules (including matters related to compensation for loss caused by an interruption of clinical research on advanced regenerative medicine); |
| 9. | Protection measures for personal information of human subjects of research; |
| 10. | Scale of research fund and financing plans; |
| 11. | Management plans for data produced in the process of clinical research on advanced regenerative medicine, including recording, collecting, and storage of such data. |
| (2) | Except as provided in paragraph (1), detailed matters necessary for preparation of a research protocol for advanced regenerative medicine shall be determined and publicly notified by the Minister of Health and Welfare. |
| Article 12 (Deliberation on Research Protocol for Advanced Regenerative Medicine) |
| (1) | Expert committees by field established under Article 13 (4) of the Act (hereinafter referred to as "expert committee") shall prepare a review report on research protocol in the competent field among the research protocols for advanced regenerative medicine submitted to the Review Committee under Article 11 (1) and submit it to the Review Committee. |
| (2) | The Review Committee shall deliberate and determine as to whether a research protocol for advanced regenerative medicine is appropriate or inappropriate based on the review report submitted pursuant to paragraph (1), and send the results thereof to the Minister of Health and Welfare without delay. |
| (3) | The Minister of Health and Welfare shall notify the relevant regenerative medical institution of the deliberation results within seven days from the date of receipt of the results of deliberation by the Review Committee under paragraph (2). |
| (4) | Except as provided in paragraphs (1) through (3), details necessary for deliberation on a research protocol for advanced research medicine shall be determined and publicly notified by the Minister of Health and Welfare. |
| Article 13 (Approval of Research Protocols for Advanced Regenerative Medicine) |
| (1) | Notwithstanding Articles 11 and 12, a regenerative medical institution that intends to obtain an approval for a research protocol for advanced regenerative medicine (limited to clinical research referred to in subparagraph 3 (a) of Article 2 of the Act) from the Minister of Food and Drug Safety pursuant to Article 12 (3) of the Act shall submit an application in the Form prescribed by Ordinance of the Prime Minister to the Review Committee, along with the following materials: |
| 1. | Research protocols for advanced regenerative medicine; |
| 2. | Details of outcomes of non-clinical trials and related data; |
| 3. | Base data on the standards for recovery, inspection, treatment, and storage of human cells, etc.; |
| 4. | Other data similar to those specified in subparagraphs 1 through 3, determined and publicly notified by the Minister of Food and Drug Safety. |
| (2) | When the Review Committee deliberates and decides, pursuant to Article 12 (1) and (2), on a research protocol for advanced regenerative medicine submitted under paragraph (1), it shall send the following materials to the Minister of Food and Drug Safety without delay. In such cases, where the Review Committee deliberates and decides on the research protocol as inappropriate, the Minister of Food and Drug Safety shall notify the relevant regenerative medical institution of the results of deliberation within seven days from the date he or she receives the following materials: |
| 1. | Data specified in the subparagraphs of paragraph (1) (including written applications submitted by applicants); |
| 2. | A review report prepared by an expert committee; |
| 3. | Data on the results of deliberation by the Review Committee. |
| (3) | Where the Minister of Food and Drug Safety deems it necessary for granting an approval for a research protocol for advanced regenerative medicine pursuant to Article 12 (3) of the Act, he or she may request the agencies, organizations, experts related to advanced biological products, or a regenerative medical institution that has filed an application for an approval of clinical research on relevant advanced regenerative medicine to submit opinions or data or provide other necessary cooperation. |
| (4) | Where the Minister of Food and Drug Safety determines on whether to grant an approval for a research protocol for advanced regenerative medicine pursuant to Article 12 (3) of the Act, he or she shall notify a regenerative medical institution and the Review Committee of the results thereof in writing. |
| (5) | Except as provided in paragraphs (1) through (4), details necessary for the procedures, methods, etc. of granting an approval for research protocols for advanced regenerative medicine shall be determined and publicly notified by the Minister of Food and Drug Safety. |
| Article 14 (Composition and Operation of Review Committee) |
| (1) | The term of office of the members of the Review Committee commissioned pursuant to Article 13 (2) of the Act shall be three years. |
| (2) | The chairperson of the Review Committee shall represent the Review Committee and preside over its affairs. |
| (3) | Where the chairperson of the Review Committee is unable to perform his or her duties due to unavoidable circumstances, a member designated by the chairperson in advance shall act on his or her behalf. |
| (4) | Where requested by at least 1/3 of all incumbent members of the Review Committee or where deemed necessary by the chairperson of the Committee, the chairperson of the Review Committee shall convene and preside over its meetings. |
| (5) | A majority of the members of the Review committee shall constitute a quorum, and any decision thereof shall require the concurring votes of a majority of those present. |
| (7) | Except as provided in paragraphs (1) through (6), matters necessary for the composition and operation of the Review Committee shall be determined by the chairperson of the Review Committee, following deliberation by the Review Committee. |
| Article 15 (Composition of Expert Committees) |
| 1. | Expert committee on cell treatment; |
| 2. | Expert committee on gene therapy; |
| 3. | Expert committee on tissue engineering treatment; |
| 4. | Expert committee on convergence treatment. |
| (2) | Each expert committee shall be comprised of not more than 12 members, including one chairperson, in consideration of gender balance, and expert members shall be appointed or commissioned by the Minister of Health and Welfare, in consultation with the Minister of Food and Drug Safety, from among experts in the relevant fields. |
| (3) | An expert committee shall review the matters deemed by the Committee chairperson to require expert review, among the matters deliberated on by the Committee. |
| (4) | An expert committee shall report the results of review under paragraph (3) to the Review Committee. |
| Article 16 (Functions of Review Committee) |
| 1. | Matters concerning the appropriateness of the grounds for non-disclosure of information by a regenerative medical institution in response to a request for disclosure of information by a human subject of research under Article 10 (7) of the Act; |
| 2. | Matters requested by the Minister of Health and Welfare in relation to measures, such as the suspension of clinical research on advanced regenerative medicine under Article 21 (4) of the Act and the subparagraphs of Article 25 of this Decree; |
| 3. | Matters concerning measures, such as suspension of use of human cells, etc. that have caused or are likely to cause any risk to the public health, under Article 40 (1) of the Act; |
| 4. | Matters concerning the scope of human cells, etc. under Article 3; |
| 5. | Matters concerning the classification of the degree of risk of clinical research on advanced regenerative medicine under Article 4; |
| 6. | Matters concerning the composition and operation of the Review Committee under Article 14 (7); |
| 7. | Matters concerning the appropriateness of a long-term follow-up plan under Article 24 (1). |
| 2. | Appropriateness of protection measures for personal information of human subjects of the research; |
| 3. | Appropriateness of the scale of research funds. |
| (3) | "Special circumstances prescribed by Presidential Decree, such as a substantial detriment to the rights of a researcher or a human subject or public interest" in the proviso of Article 14 (3) of the Act means any of the following cases where the Review Committee resolves to keep the meeting minutes confidential: |
| 1. | Where the disclosure of minutes seriously impedes the prevention of a crime, investigation, filing and maintenance of a prosecution, or a trial underway; |
| 2. | Where it concerns managerial or trade secrets of a corporation, organization, or individual, the disclosure of which is feared to substantially undermine the legitimate interests of the relevant corporation, etc.; |
| 3. | Where it is classified as a secret or restricted from disclosure in accordance with other statutes or regulations; |
| 4. | Other cases where it is likely to significantly infringe on public interest. |
| Article 17 (Permission for Advanced Regenerative Medicine Cell Processing Facility) |
| (1) | The standards for the facilities, personnel, and equipment for cell processing services (hereinafter referred to as "cell processing services") under the former part of Article 15 (1) of the Act shall be classified as follows: |
| 1. | Standards for facilities: To be equipped with all of the following facilities: |
| (a) | Recovery rooms for collection of human cells, etc. (only applicable to cases where a medical institution under Article 3 of the Medical Service Act (hereinafter referred to as "medical institution") performs cell processing services): Provided, That where recovery services are entrusted pursuant to Article 17 (1) of the Act, the relevant facilities need not be installed; |
| (b) | Testing and examination rooms for quality control of human cells, etc.: Provided, That where inspection services are entrusted pursuant to Article 17 (1) of the Act, the relevant facilities need not be installed; |
| (c) | Treatment rooms for treatment of human cells, etc.; |
| (d) | Depository or storage facilities for sanitary storage of human cells, etc.; |
| (e) | Repository of records for keeping records of performing duties concerning human cells, etc.; |
| (f) | Other facilities necessary for cell processing services, which are determined and publicly notified by the Minister of Food and Drug Safety; |
| 2. | Standards for personnel: To have all of the following personnel: |
| (a) | At least one quality manager who leads and supervises cell processing services; |
| (b) | At least one staff member or researcher in charge of cell processing services; |
| (c) | At least one staff member or researcher in charge of record-keeping duties; |
| (d) | Other personnel necessary for cell processing services, who are determined and publicly notified by the Minister of Food and Drug Safety; |
| 3. | Standards for equipment: To have all of the following equipment: |
| (a) | Air conditioning systems for preventing pollution and maintaining temperature and humidity; |
| (b) | Testing and examination equipment for blood tests, microbiological tests, etc.; |
| (c) | Refrigeration equipment and automatic temperature recording systems for the storage of human cells, etc.; |
| (d) | Other equipment necessary for cell processing services, which are determined and publicly notified by the Minister of Food and Drug Safety. |
| (2) | Matters necessary for the details, operating methods, etc. of standards for facilities, personnel, and equipment under each subparagraph of paragraph (1) shall be determined and publicly notified by the Minister of Food and Drug Safety. |
| (4) | Any person who intends to file a notification under Article 15 (3) of the Act shall submit to the Minister of Food and Drug Safety a written notification in the Form prescribed by Ordinance of the Ministry of Environment, which shall be accompanied by the following documents: |
| 1. | Documents for permission according to the following classification: |
| (a) | In cases falling under Article 28 (1) of the Act: A document certifying that the applicant has obtained permission to conduct the management business of human cells, etc. (hereinafter referred to as "management business of human cells, etc.") under Article 28 (1) of the Act; |
| 2. | A business plan for cell processing services; |
| 3. | Current status of facilities, personnel, and equipment for cell processing services (only required for persons who fall under the subparagraphs of Article 28 (2) of the Act). |
| Article 18 (Records of Cell Processing Services) |
| (1) | The head of an advanced regenerative cell processing facility referred to in the former part of Article 15 (1) of the Act (hereinafter referred to as "cell processing facility") shall record the following matters whenever it supplies human cells, etc. to regenerative medical institutions pursuant to paragraph (4) of that Article and shall keep the records for 20 years from the date of supply: |
| 2. | Matters concerning the recovery of human cells, etc. and the results thereof (including information on medical institutions and persons responsible for such recovery); |
| 3. | Matters concerning the type of human cells, etc., the procedures, methods, and results of examination and processing; |
| 4. | Matters concerning the regenerative medical institutions that receive human cells, etc. and the procedures and methods of supplying the cells, etc.; |
| 5. | Other matters determined and publicly notified by the Minister of Health and Welfare, which are necessary for the supply of human cells, etc. |
| (2) | The head of a cell processing facility shall submit a report prescribed by Ordinance of the Ministry of Health and Welfare, accompanied by records on the performance of cell treatment services for the preceding year, to the head of an advanced regenerative medical safety management institution referred to in Article 19 (1) of the Act (hereinafter referred to as "safety management institution") by the end of February each year. |
| (3) | Other details necessary for the recording, storage and reporting of cell processing services shall be determined and publicly notified by the Minister of Health and Welfare. |
| Article 19 (Renewal of Permit of Cell Processing Facility) |
| (1) | The head of a cell processing facility who intends to renew a permit granted to the cell processing facility pursuant to Article 15 (6) of the Act shall apply for the renewal of the permit to the Minister of Food and Drug Safety at least 120 days prior to the expiration date thereof, as prescribed by Ordinance of the Prime Minister. |
| (2) | Where the Minister of Food and Drug Safety determines whether to renew the permit of a cell processing facility pursuant to Article 15 (6) of the Act, he or she shall take into account the following matters: |
| 1. | Whether the standards for the facilities, personnel, and equipment specified in the subparagraphs of Article 17 (1) are appropriate; |
| 2. | Details of performance records and activities of cell processing services during the previous period of validity; |
| 3. | Whether the relevant statutes or regulations governing cell processing services have been violated during the previous period of validity. |
| (3) | Where the Minister of Food and Drug Safety deems it necessary for the renewal of a permit of a cell processing facility under Article 15 (6) of the Act, he or she may inform the head of the relevant cell processing facility of the fact that the permit cannot be renewed if not renewed until the expiration of the period of validity and of the renewal procedures thereof. |
| Article 20 (Consent to Recovery of Human Cells) |
| (1) | A medical personnel shall, before obtaining a written consent pursuant to Article 16 (3) and (4) of the Act, fully explain the matters specified in the subparagraphs of paragraph (3) of that Article to a person subject to recovery of human cells, etc., his or her parents, or his or her legal representative. |
| 1. | Purpose of use of human cells, etc.; |
| 2. | Types and doses of human cells, etc.; |
| 3. | Period of preservation of human cells, etc. recovered and cells made from human cells, etc. as raw materials; |
| 4. | Whether the human cells, etc. are provided to other institutions or for any other purpose of use. |
| Article 21 (Recovery of Xenogenic Cells) |
| (1) | A person who is not a medical personnel may, pursuant to Article 16 (6) of the Act, recover xenogenic cells, tissues for the extraction of xenogenic cells, or xenogenic organs (hereinafter referred to as "xenogenic cells, etc.”) at an animal testing institution prescribed in subparagraph 13 of Article 2 of the Animal Protection Act, in any of the following cases: <Amended on Apr. 27, 2023> |
| (2) | A person who recovers xenogenic cells, etc. under paragraph (1) shall comply with the following matters: |
| 1. | The subject animals shall be checked as to whether they are in a suitable condition for the recovery of xenogenic cells, etc. through perusal of clinical history, medical examination, checkup, etc.; |
| 2. | Measures shall be taken to prevent the subject animals from being contaminated with bacteria, etc. in the course of recovering xenogenic cells, etc. |
| (3) | Except as provided in paragraphs (1) and (2), details necessary for recovering xenogenic cells, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 22 (Scope of Agencies Entrusted with Cell Processing Services) |
| (1) | Pursuant to Article 17 (1) of the Act, the head of a cell processing facility may entrust the affairs of recovery or inspection of human cells, etc. to the institutions categorized in the following subparagraphs: <Amended on Dec. 28, 2021; Apr. 27, 2023; Aug. 16, 2023> |
| 1. | Recovery: Any of the following institutions: |
| (a) | Medical institutions; |
| 2. | Inspection: Any of the following institutions: |
| (a) | Medical institutions; |
| (c) | A person who has obtained permission for the manufacturing business of advanced biological products pursuant to Article 23 (1) of the Act (hereinafter referred to as "manufacturer"); |
| (d) | A person who has obtained permission for the management business of human cells, etc. pursuant to Article 28 (1) of the Act (hereinafter referred to as "management business entity of human cells, etc."); |
| (2) | The head of a cell processing facility who entrusts affairs of recovery or inspection of human cells, etc. pursuant to Article 17 (1) of the Act shall prepare a contract including the following matters: |
| 1. | Details of entrustment; |
| 2. | Period of entrustment; |
| 4. | Responsibilities and obligations of the entrusting party and the entrusted party; |
| 5. | Cancellation of entrustment; |
| 6. | Other matters equivalent to those referred to in subparagraphs 1 through 5 and deemed necessary by the Minister of Food and Drug Safety. |
| (3) | Where the head of a cell processing facility entrusts affairs of recovery or inspection of human cells, etc. pursuant to Article 17 of the Act or cancels such entrustment, he or she may post the details thereof on the website of the relevant institution. |
| (4) | Except as provided in paragraphs (1) through (3), details necessary for the procedures, methods, etc. of entrustment of affairs of recovery or inspection of human cells, etc. shall be determined and publicly notified by the Minister of Food and Drug Safety. |
| Article 23 (Affairs of Safety Management Institutions) |
| 1. | Establishment and operation of an information system to collect and manage clinical research data on advanced regenerative medicine; |
| 2. | Survey and research on analysis and utilization of clinical research data on advanced regenerative medicine; |
| 3. | Standardization and disclosure of clinical research data on advanced regenerative medicine; |
| 4. | Education and publicity on the safety management of clinical research on advanced regenerative medicine. |
| Article 24 (Plans for Long-Term Follow-up of Clinical Research on Advanced Regenerative Medicine) |
| (1) | The head of a safety management institution who intends to conduct a long-term follow-up study of clinical research on advanced regenerative medicine pursuant to Article 21 (1) of the Act shall formulate a long-term follow-up study plan including the following matters after consulting with a regenerative medical institution and undergo deliberation thereon by the Review Committee: |
| 1. | Targets and methods of a long-term follow-up study; |
| 2. | Matters to be complied with by regenerative medical institutions and those subject to long-term follow-up study; |
| 3. | Other matters necessary to conduct a long-term follow-up study. |
| (2) | Where the head of a safety management institution conducts a long-term follow-up study of clinical research on advanced regenerative medicine pursuant to Article 21 (1) of the Act, he or she shall submit to the Minister of Health and Welfare an annual report on the long-term follow-up study including the assessment of safety and efficacy of relevant clinical research on advanced regenerative medicine, as prescribed by Ordinance the Minister of Health and Welfare. |
| Article 25 (Necessary Measures for Public Health) |
“Measures necessary for public health ... such as the suspension of clinical research on advanced regenerative medicine and the preparation of measures to protect patients, etc., as prescribed by Presidential Decree” in Article 21 (4) of the Act means the following measures: | 1. | Suspension of clinical research on advanced regenerative medicine (including clinical research on advanced regenerative medicine related or similar to the clinical research on advanced regenerative medicine subject to a long-term follow-up study); |
| 2. | Verification of health conditions of human subjects of research and persons subject to a long-term follow-up study, including occurrence of a transitional disease, and isolation measures. In such cases, isolation measures may be taken only where a contagious disease, etc. is likely to occur; |
| 3. | An epidemiological investigation to identify the causes, etc. of adverse reactions; |
| 4. | Disclosure of information on the details of the measures taken under subparagraphs 1 through 3 and the findings of a long-term follow-up study. |
CHAPTER IV PERMISSION FOR AND SAFETY MANAGEMENT OF ADVANCED BIOLOGICAL PRODUCTS
| Article 26 (Facility Standards for Manufacturing Business of Advanced Biological Products) |
| (1) | The facility standards for the manufacturing business of advanced biological products under the former part of Article 23 (1) of the Act shall be as follows: |
| 1. | The manufacturing business shall have a working place where the manufacturing process of advanced biological products is completed and equipment and instruments necessary for the manufacturing thereof; |
| 2. | The manufacturing business shall have the testing and inspection rooms in which a testing and inspection can be conducted independently for the quality control of raw materials, materials, and advanced biological products, and equipment and instruments necessary for the testing and inspection; |
| 3. | The manufacturing business shall have the depository or storage facilities to store the raw materials, materials, and advanced biological products in a safe and sanitary manner; |
| 4. | The manufacturing business shall have the records repository equipped with an access security system, equipment for business records, and equipment for keeping business records, etc. |
| (2) | Where any of the following persons intends to obtain permission for the manufacturing business of advanced biological products pursuant to the former part of Article 23 (1) of the Act, if the facilities, equipment, instruments for the manufacturing and import of the relevant pharmaceuticals or advanced biological products comply with the standards referred to in the subparagraphs of paragraph (1), and the pharmaceuticals and advanced biological products are not likely to contaminate one another, the relevant facilities, equipment, and instrument shall be deemed the facilities, equipment, and instruments for manufacturing the advanced biological products: |
| 1. | A person who makes a notification of import business under Article 27 (1) of the Act (hereinafter referred to as "importer"); |
| (3) | Where a manufacturer entrusts another manufacturer with part of the business of manufacturing, or testing and inspection of advanced biological products, he or she may not be equipped with all or some of the facilities, equipment, and instruments specified in paragraph (1) 1 and 2. |
| (4) | Except as provided in paragraphs (1) through (3), necessary matters concerning the detailed standards and operating methods of the manufacturing facilities of advanced biological products shall be prescribed by Ordinance of the Prime Minister. |
| Article 27 (Facility Standards for Import Business of Advanced Biological Products) |
| 1. | An importer shall have a place of business to manage the importation, distribution, and sales of advanced biological products and the equipment and instruments necessary for the importation, distribution, and sales thereof; |
| 2. | An importer shall have a testing laboratory that can independently conduct tests and inspections for the quality control of advanced biological products as well as equipment and instruments necessary for such tests and inspections; |
| 3. | An importer shall have a depository or storage facilities which can preserve advanced biological products in a safe and sanitary manner; |
| 4. | An importer shall have a record repository with an access security system, and equipment for business records, and equipment for keeping business records, etc. |
| (2) | Where any of the following persons intends to file a notification of import business of advanced biological products pursuant to the former part of Article 27 (1) of the Act, if the facilities, equipment, and instruments for the manufacture, import, sales, etc. of the relevant drugs or advanced biological products comply with the standards specified in the subparagraphs of paragraph (1), the relevant facilities, equipment, and instruments shall be deemed the facilities, equipment, and instruments for the import of advanced biological products: |
| (3) | Except as provided in paragraphs (1) and (2), matters necessary for the detailed standards and operating methods of the facilities of import business of advanced biological products shall be prescribed by Presidential Decree. |
| Article 28 (Standards for Permission of Management Business of Human Cells) |
| (1) | The standards for the facilities, equipment, personnel, and quality control systems of the management business of human cells, etc. that engages in the management of human cells, etc. under the former part of Article 28 (1) of the Act (hereinafter referred to as "management affairs of human cells, etc.") shall be as follows: |
| 1. | Standards for facilities: The business shall be equipped with all of the following facilities: |
| (a) | Recovery rooms for recovering human cells, etc. (only applicable to cases where medical institutions conduct management affairs of human cells, etc.): Provided, That where the recovery affairs of human cells, etc. are entrusted pursuant to Article 17 (1) of the Act, the relevant facilities need not be installed: |
| (b) | Processing rooms for processing human cells, etc.; |
| (c) | Testing laboratories and inspection rooms for quality control of human cells, etc.: Provided, That where inspection affairs are entrusted pursuant to Article 17 (1) of the Act, the relevant facilities need not be installed; |
| (d) | Depository or storage facilities for sanitary preservation of human cells, etc.; |
| (e) | Record repository for keeping business records of human cells, etc.; |
| (f) | Other facilities necessary for management affairs of human cells, etc., which are determined and publicly notified by the Minister of Food and Drug Safety; |
| 2. | Standards for personnel: The business shall have the following personnel: |
| (a) | At least one quality manager who directs and supervises management affairs of human cells, etc.; |
| (b) | At least one person in charge or a researcher who performs management affairs of of human cells, etc.; |
| (c) | At least one person in charge or researcher who performs duties of keeping records; |
| (d) | Other personnel determined and publicly notified by the Minister of Food and Drug Safety as necessary for management affairs of human cells, etc.; |
| 3. | Standards for equipment: The business shall be equipped with all of the following equipment: |
| (a) | Air conditioning systems for preventing pollution and maintaining temperature and humidity; |
| (b) | Testing and inspection equipment for blood tests, microbiological tests, etc.; |
| (c) | Refrigeration equipment and automatic temperature recording systems for storing human cells, etc.; |
| (d) | Other equipment necessary for the management affairs of human cells, etc., determined and publicly notified by the Minister of Food and Drug Safety; |
| 4. | Standards for quality control systems: The business shall comply with the following standards: |
| (a) | The standard work process for management affairs of human cells, etc. shall be documented and executed; |
| (b) | The duties, responsibilities, authority, etc. of the members of an organization shall be documented and executed; |
| (c) | Various results and records related to management affairs of human cells, etc. shall be prepared and preserved in writing; |
| (d) | A self-check system to maintain the appropriateness of human cell management affairs shall be established; |
| (e) | Other standards determined and publicly notified by the Minister of Food and Drug Safety for quality control of management affairs of human cells, etc. shall be complied with. |
| (2) | Other matters necessary for detailed standards and operating methods of the facilities, personnel, equipment, and quality control systems under paragraph (1) shall be determined and publicly notified by the Minister of Food and Drug Safety. |
| Article 29 (Research Targets for Long-term Follow-up Study) |
| (1) | Advanced biological products subject to the designation as research targets for a long-term follow-up study under Article 30 (1) of the Act (hereinafter referred to as "long-term follow-up study") shall be as follows: |
| 1. | Cell therapy products containing human stem cells; |
| 2. | Advanced biological products including animal tissues and cells; |
| 3. | Advanced biological products determined and publicly notified by the Minister of Food and Drug Safety, over which it is necessary to ascertain whether any abnormalities occur during a certain period of time after gene therapy products, etc. are administered. |
| (2) | The Minister of Food and Drug Safety may revoke the designation of advanced biological products as research targets for a long-term follow-up study, if he or she deems that such a long-term follow-up study is not necessary for the advanced biological products. |
| (3) | If the Minister of Food and Drug Safety deems it necessary for the designation or revocation of designation of advanced biological products as research targets for a long-term follow-up study, he or she may seek advice from the Review Committee. |
| (4) | Where the Minister of Food and Drug Safety designates or, revokes the designation of, advanced biological products subject to a long-term follow-up study, he or she shall notify a person who has obtained an approval of a clinical trial protocol under Article 34 (1) of the Pharmaceutical Affairs Act (hereinafter referred to as "a person who has obtained approval of a clinical trial protocol”, the approval of which shall be limited to advanced biological products), a person who has obtained permission by item for the relevant advanced biological products, and an importer of the details of the designation or revocation in writing. In such cases, if the Minister of Food and Drug Safety deems it necessary for the safety control of advanced biological products, he or she may post the details thereof on the website of the Ministry of Food and Drug Safety. |
| (5) | When a person who has obtained approval of a clinical trial protocol, a person who has obtained permission by item for the relevant advanced biological products, and an importer thereof receives a written notification of designation, or revocation of designation, of advanced biological products subject to a long-term follow-up study pursuant to the former part of paragraph (4), he or she shall provide the relevant details and measures to be taken to the clinical trial institutions, medical institutions, or doctors, dentists, pharmacists, etc. handling the relevant advanced biological products. |
| (6) | Except as provided in paragraphs (1) through (5), detailed matters necessary for the procedures, methods, etc. of designation, or revocation of designation, of advanced biological products subject to a long-term follow-up study shall be determined and publicly notified by the Minister of Food and Drug Safety. |
| Article 30 (Procedures and Methods of Long-Term Follow-Up Study) |
| (1) | Where a person who has obtained an approval of a clinical trial protocol, a person who has obtained permission by item of advanced biological products, and an importer thereof formulates a long-term follow-up study plan pursuant to Article 30 (2) of the Act, he or she shall submit the relevant long-term follow-up study plan to the Minister of Food and Drug Safety without delay. |
| (2) | If necessary to conduct a long-term follow-up study more efficiently, a person who has obtained approval of a clinical trial protocol, a person who has obtained permission by item for advanced biological products, and an importer thereof may establish and operate a consultative body for business affairs, comprised of clinical trial institutions, medical institutions, doctors, dentists, pharmacists, or experts in advanced biological products. |
| (3) | A person who has obtained approval of a clinical trial protocol, a person who has obtained permission by item of advanced biological products, and an importer thereof shall report the details, results, etc. of a long-term follow-up study to the Minister of Food and Drug Safety on a date that elapses one year from the date he or she first sells and supplies advanced biological products designated as research targets for a long-term follow-up study. |
| (4) | Except as provided in paragraphs (1) through (3), detailed matters necessary for the procedures and methods of a long-term follow-up study shall be determined and publicly notified by the Minister of Food and Drug Safety. |
| Article 31 (Reporting Methods on Adverse Events) |
| (1) | When a person who has obtained approval of a clinical trial protocol, a person who has obtained permission by item of advanced biological drugs, or an importer becomes aware of any serious adverse events referred to in Article 30 (3) of the Act (hereinafter referred to as "adverse event"), he or she shall report the fact of occurrence of the adverse event concerned and a plan for investigation and analysis thereof to the Minister of Food and Drug Safety within 15 days from the date he or she becomes aware of the fact. |
| (2) | A person who has obtained approval of a clinical trial protocol, a person who has obtained permission by item of advanced biological drugs, and an importer thereof shall report the results of an investigation and analysis of adverse events, including the matters specified in the following subparagraphs, to the Minister of Food and Drug Safety within six months from the date he or she submits the plan for investigation and analysis of adverse events under paragraph (1): Provided, That where any extenuating circumstances exist, making it impractical to complete the investigation and analysis within the specified period, he or she may report such circumstances to the Minister of Food and Drug Safety and extend the period for investigation and analysis by up to three months after reporting: |
| 1. | Types and details of adverse events; |
| 2. | Causes of adverse events; |
| 3. | Causation between advanced biological products and adverse events; |
| 4. | Countermeasures against adverse events; |
| 5. | Domestic and international evaluation data on adverse events; |
| 6. | Other matters deemed necessary by the Minister of Food and Drug Safety that are equivalent to the provisions of subparagraphs 1 through 5. |
| (3) | Where a person who has obtained approval of a clinical trial protocol, a person who has obtained permission by item of advanced biological products, and an importer thereof makes a report under paragraphs (1) and (2), he or she may file a report using the computer network referred to in Article 32 (3) 1 of the Act. |
| (4) | Except as provided in paragraphs (1) through (3), detailed matters necessary for the methods, procedures, etc. of reporting adverse events shall be determined and publicly notified by the Minister of Food and Drug Safety. |
| Article 32 (Consent to Registration of History of Administration of Advanced Biological Products) |
| (1) | When a doctor, dentist, or pharmacist who handles advanced biological products subject to a long-term follow-up study under Article 30 (4) of the Act intends to register personal information of those subject to administration and history of administered medicines with a regulatory science center referred to in Article 32 (1) of the Act (hereinafter referred to as "Regulatory Science Center"), he or she shall obtain a written consent from the persons subject to administration, describing the following matters: |
| 1. | The fact that the advanced biological products to be administered are subject to a long-term follow-up study; |
| 2. | The fact that personal information of those administered with medicines and history of administered medicines are registered with the Regulatory Science Center; |
| 3. | Matters concerning the methods, procedures, etc. of withdrawal of a written consent; |
| 4. | Matters concerning protection of personal information; |
| 5. | Other matters corresponding to those listed in subparagraphs 1 through 4, determined and publicly notified by the Minister of Food and Drug Safety. |
| (2) | Notwithstanding paragraph (1), where a person subject to administration is a minor, a written consent shall be obtained from the principal and his or her parents (referring to the legal representative if the principal has no parent), and where the principal is incapable of, or incompetent for, giving a consent, a written consent shall be obtained from the following representatives. In such cases, a consent of the representative shall not be contrary to the intention of the person subject to administration: |
| 1. | The legal representative; |
| 2. | In the absence of a legal representative, the spouse, lineal ascendants, lineal descendants, siblings, and children shall act as the representative of the principal in the aforementioned order; if there are two or more lineal ascendants or descendants, the representative shall be determined under agreement by and between such ascendants or descendants; if they fail to reach an agreement, the oldest person among them shall act as the representative of the principal. |
| (3) | A person who intends to obtain a written consent under paragraphs (1) and (2) shall sufficiently explain the matters specified in the subparagraphs of paragraph (1) to a person subject to administration or his or her representative before obtaining such written consent. |
| Article 33 (Registration of History of Administration of Advanced Biological Drugs) |
| (1) | A doctor, dentist, or pharmacist who handles advanced biological drugs subject to a long-term follow-up study shall, pursuant to Article 30 (4) of the Act, register the personal information of a person subject to administration and details of administered medication using a computer network under Article 32 (3) 1 of the Act within seven days from the date of administration of medication. |
| (2) | If the registered matters under Article 30 (4) of the Act have any omissions or errors, the head of the Regulatory Science Center may request a doctor, dentist, or pharmacist handling advanced biological products subject to a long-term follow-up study to correct or supplement them. |
| Article 34 (Registration of Details of Sales and Supply of Advanced Biological Drugs) |
| (1) | Each person who has obtained approval of a clinical trial protocol, person who has obtained permission by item of advanced biological products, and importer thereof shall register the details of the sale and supply of advanced biological products subject to a long-term follow-up study through the computer network referred to in Article 32 (3) 1 of the Act whenever he or she sells and supplies the relevant advanced biological products. |
| (2) | Where the matters registered under Article 30 (5) of the Act contain any omissions, errors, etc., the head of the Regulatory Science Center may request a person who has obtained approval of a clinical trial protocol, a person who has obtained permission by item of advanced biological products, and an importer thereof to correct or supplement them. |
| Article 35 (Necessary Measures for Public Health) |
"Measures necessary for public health prescribed by Presidential Decree, such as the suspension of clinical trials, the suspension of manufacture, import, or sale of relevant items, and an order for recall and destruction" in Article 30 (6) of the Act means any of the following measures: | 1. | An order to suspend a clinical trial; |
| 2. | An order to suspend the manufacture and import of, or sale and supply of, the relevant advanced biological products; |
| 3. | An order to recall and discard the relevant advanced biological products; |
| 4. | An order to submit a plan for protective measures for patients; |
| 5. | An order to suspend the use of advanced biological products in medical institutions; |
| 6. | Other measures equivalent to the provisions of subparagraphs 1 through 5, which are determined and publicly notified by the Minister of Food and Drug Safety to ensure public safety. |
| Article 36 (Business Affairs of Regulatory Science Center) |
| 1. | Collection, analysis, and provision of safety information on advanced biological products; |
| 2. | Establishment of domestic and international cooperative network for the safety control of advanced biological products; |
| 3. | Assistance in review of whether to revoke the designation of research targets for a long-term follow-up study under Article 29 (2); |
| 4. | Assistance in the review of a long-term follow-up study plan submitted under Article 30 (1); |
| 5. | Assistance in the review of the details and findings of a long-term follow-up study reported under Article 30 (3); |
| 6. | Support for the transfer of data, etc. related to a long-term follow-up study under Article 44 of the Act; |
| 7. | Other matters deemed necessary by the Minister of Food and Drug Safety for the safety control of advanced biological products. |
| (2) | Where necessary for a consultation on important matters concerning a long-term follow-up study and support for advanced biological products, the head of the Regulatory Science Center may organize and operate a business consultative body comprised of relevant public officials, executives and employees of the Regulatory Science Center, experts in advanced biological products, etc. |
| Article 37 (Investigation and Inspection by Relevant Public Officials) |
Where the Minister of Health and Welfare or the Minister of Food and Drug Safety intends to direct a relevant public official to conduct an investigation or inspection pursuant to Article 39 (1) 2 and (2) 2 of the Act, he or she shall notify those subject to the investigation or inspection of matters concerning the implementation of relevant investigation or inspection, such as the scope, date, method, and matters requiring cooperation, by seven days before the date of investigation or inspection: Provided, That if there is an urgent need for an investigation or inspection, or if unavoidable circumstances exist where, given the nature of the relevant investigation or inspection, an advance notice would make the objectives of the investigation or inspection unattainable, the person subject to the investigation or inspection may be investigated or inspected without being given a prior notice.
| Article 38 (Transfer of Data upon Closure of Business) |
Anyone who intends to process or transfer data on human cells, etc. or a long-term follow-up study data pursuant to Article 44 of the Act shall process or transfer the relevant data, etc. according to the following classifications within one month from the date of closure or suspension of business, or the date of revocation of permission, etc. under Article 42 of the Act: | 1. | In cases of processing (limited to suspension of business): The person shall submit a plan for storage including the following matters to the Minister of Health and Welfare (only applicable to the regenerative medical institutions) or the Minister of Food and Drug Safety. In such cases, if the plan for storage has any omissions or errors, the Minister of Health and Welfare or the Minister of Food and Drug Safety may request the relevant storage plan to be corrected or supplemented: |
| (f) | Matters concerning measures to be taken if storage becomes infeasible; |
| (g) | Other matters corresponding to the provisions of items (a) through (f), which are deemed necessary by the Minister of Health and Welfare or the Minister of Food and Drug Safety; |
| 2. | In cases of transfer: The person shall transfer the relevant data, etc. to the institutions classified as follows: |
| (a) | Regenerative medical institutions: Safety management institutions; |
| (b) | Cell treatment facilities, management entities for human cells, etc., persons who have obtained approval of clinical trial protocols, persons who have obtained permission by item, and importers: Regulatory Science Center. |
| Article 39 (Standards and Procedures for Imposition of Penalty Surcharges) |
| 1. | Regenerative medical institutions: Attached Table 1; |
| 2. | A manufacturer, importer, or person who has obtained permission by item of advanced biological products, a management entity for human cells, etc. and a cell treatment facility: Attached Table 2. |
| (2) | Where the Minister of Health and Welfare or the Minister of Food and Drug Safety intends to impose a penalty surcharge pursuant to Article 45 (1) of the Act, he or she shall give a written notice of payment of penalty surcharges specifying the type of violations concerned, the amount of penalty surcharges, the method for filing an objection, the period for raising an objection, etc. |
| (3) | Any person notified under paragraph (2) shall pay the penalty surcharges to a receiving agency determined by the Minister of Health and Welfare or the Minister of Food and Drug Safety, within 20 days from the date of receipt of such notice: Provided, That where such payment cannot be made within the specified period due to an act of God or any other unavoidable cause, the payment shall be made within seven days from the date such cause ceases to exist. |
| (4) | Upon receipt of the penalty surcharges under paragraph (3), the receiving agency shall issue a receipt to the person who has paid the penalty surcharges, and notify the Minister of Health and Welfare or the Minister of Food and Drug Safety of the receipt thereof without delay. |
| Article 40 (Procedures for Disposition against Penalty Surcharge Defaulters) |
| (1) | Where any person liable to pay a penalty surcharge pursuant to the main clause of Article 45 (4) of the Act fails to pay the penalty surcharge by the deadline for payment, the Minister of Health and Welfare or the Minister of Food and Drug Safety shall issue a reminder within 15 days after the deadline for payment elapses. In such cases, the deadline for payment shall be within 10 days after the date the reminder is issued. |
| (2) | Where a person who has defaulted on the payment of a penalty surcharge fails to pay the penalty surcharge by the relevant deadline for payment even after receiving a reminder under paragraph (1), the Minister of Health and Welfare or the Minister of Food and Drug Safety shall revoke the disposition of the imposition of the penalty surcharge, and issue a disposition of business suspension under Article 42 of the Act, or collect the penalty surcharge in the same manner as delinquent national taxes are collected: Provided, That in cases falling under the proviso of Article 45 (4) of the Act, the penalty surcharge shall be collected in the same manner as delinquent national taxes are collected. |
| (3) | Where the Minister of Health and Welfare or the Minister of Food and Drug Safety revokes the disposition of the imposition of penalty surcharges pursuant to the main clause of Article 45 (4) of the Act and issues a disposition of business suspension under Article 42 of the Act, he or she shall notify the person subject to such disposition of the details thereof in writing. In such cases, the written notice shall include matters necessary for the disposition of business suspension, such as grounds for changing the original disposition and the period for the disposition of business suspension. |
CHAPTER Ⅵ SUPPLEMENTARY PROVISIONS
| Article 41 (Delegation or Entrustment of Authority or Duties) |
| (1) | The Minister of Health and Welfare shall delegate the following authority to the head of a safety management institution, pursuant to Article 47 (1) of the Act: |
| 1. | Making a request for reporting and submission of documents by the head of a regenerative medical institution under Article 39 (1) 1 of the Act; |
| 3. | Orders to take measures, such as suspension of use, recall or destruction, or other necessary measures under Article 40 (1) of the Act; |
| (2) | Pursuant to Article 47 (1) of the Act, the Minister of Health and Welfare shall delegate his or her authority to impose and collect administrative fines under Article 63 (3) 4 of the Act to a Special Metropolitan City Mayor, Metropolitan City Mayor, Special Self-Governing City Mayor, Do Governor, or Special Self-Governing Province Governor. |
| (3) | The Minister of Food and Drug Safety shall delegate the following authority to the head of a local food and drug safety office pursuant to Article 47 (2) of the Act: |
| (c) | Receipt of notification of closure, temporary suspension, or resumption of business under the main clause of Article 15 (5) of the Act; |
| 2. | The following authority concerning the manufacturing business of advanced biological products under Article 23 of the Act: |
| (b) | Receipt of notification of a contract manufacturing and distribution business filed pursuant to the former part of Article 23 (3) of the Act; |
| (c) | Granting permission for modification, or acceptance of notification of modification, under the former part of Article 23 (7) of the Act; |
| 4. | The following authority over the import business of advanced biological products under Article 27 of the Act: |
| 5. | The following authority over the management business of human cells, etc. under Article 28 of the Act: |
| (b) | Acceptance of notification of closure, temporary suspension, or resumption of business under the main clause of Article 28 (3) of the Act; |
| (c) | Renewal of a permit under the main clause of Article 28 (4) of the Act and verification prescribed in the proviso of that paragraph; |
| 6. | Instructions given under Article 39 (2) of the Act (excluding a person who has obtained approval of a clinical trial protocol); |
| (a) | Orders to take measures, such as suspension of use, recall, and destruction, or other necessary measures under Article 40 (1) of the Act; |
| 9. | Revocation of permission or of acceptance of notification, closure of a contract manufacturing business office or place of business (limited to a notification filed under Article 27 (1) of the Act), an order to prohibit manufacture or importation of an item, or an order to fully or partially suspend business, under Article 42 (2) of the Act; |
| 12. | Imposition and collection of administrative fines under Article 63 of the Act (excluding a person who has obtained approval of a clinical trial protocol). |
| (4) | The Minister of Food and Drug Safety shall entrust the Regulatory Science Center with the following duties under Article 47 (4) of the Act: <Amended on Aug. 16, 2023> |
| 2. | Receipt of long-term follow-up study plans under Article 30 (1); |
| 3. | Receipt of reports on the details, findings, etc. of a long-term follow-up study under Article 30 (3); |
| 4. | Receipt of reports on occurrence of adverse events and plans for investigation and analysis of adverse events under Article 31 (1). |
| Article 42 (Content of False or Exaggerated Advertisement) |
| 1. | Details of clinical research on advanced regenerative medicine, which fails to receive a notification of adequacy under Article 12 (2) of the Act; |
| 2. | Content by which a medical institution other than a regenerative medical institution can be misunderstood as conducting clinical research on advanced regenerative medicine; |
| 3. | Content by which a person without permission as a cell processing facility or a person other than a management entity of human cells, etc., may be misunderstood as collecting, examining, processing human cells, etc.; |
| 4. | False or medically unrecognized content concerning the efficacy of clinical research on advanced regenerative medicine and treatment and quality of human cells, etc. |
| Article 43 (Handling of Sensitive Information and Personally Identifiable Information) |
| (1) | If it is inevitable for conducting the following business affairs, the Minister of Health and Welfare (including persons to whom relevant authority has been delegated under Article 41 (1) and (2)) or the Minister of Food and Drug Safety (including persons to whom relevant authorities or duties have been delegated or entrusted under Article 41 (3) or (4)) may manage the health information referred to in Article 23 of the Personal Information Protection Act, information that constitutes criminal history records referred to in subparagraph 2 of Article 18 of Enforcement Decree of that Act, or resident registration number or alien registration number under subparagraph 1 or 4 of Article 19 of that Decree: Provided, That in the cases of conducting business affairs specified in subparagraph 1, 3, 14, and 15, the health information referred to in Article 23 of the Personal Information Protection Act and the information that constitutes criminal history records referred to in subparagraph 2 of Article 18 of Enforcement Decree of that Act shall be excluded herefrom: <Amended on Dec. 20, 2022> |
| 2. | Affairs concerning deliberation and approval of protocols for clinical research on advanced regenerative medicine under Article 12 of the Act; |
| 3. | Affairs concerning permission and modified permission for cell processing facilities, and renewal of permits therefor under Article 15 of the Act; |
| 5. | Affairs concerning receipt of reports on the results of a long-term follow-up of clinical research on advanced regenerative medicine pursuant to Article 21 (3) and (4) of the Act and necessary measures for public health; |
| (a) | Affairs concerning the permission for manufacturing business of advanced biological products, permission for modification thereof, and renewal of permits; |
| (b) | Affairs concerning receipt of notification of the contract manufacturing business of advanced biological products, receipt of modified notification thereof, and renewal of certificates of notification; |
| 7. | Affairs concerning acceptance of notification filed by a manufacturing manager of advanced biological products under Article 24 of the Act; |
| (a) | Affairs concerning acceptance of notification of import business of advanced biological products and receipt of modified notification; |
| (b) | Affairs concerning acceptance of notification of an import manager and renewal of a certificate of notification, which are applied mutatis mutandis pursuant to Article 27 (5) of the Act; |
| 9. | Affairs concerning permission and modified permission for management business of human cells, etc., and renewal of permits under Article 28 of the Act; |
| 10. | Affairs concerning receipt of reports on the results of investigation and analysis of adverse events under Article 30 (3) of the Act; |
| 12. | Affairs concerning instructions for reporting, investigation, and collection, etc. under Article 39 of the Act; |
| 15. | Affairs concerning imposition and collection of penalty surcharges prescribed in Article 45 of the Act; |
| (2) | Where it is inevitable for conducting the following affairs, the head of a safety management institution may process data including health information prescribed in Article 23 (1) of the Personal Information Protection Act, and data including resident registration numbers and alien registration numbers prescribed in subparagraphs 1 and 4 of Article 19 of the Enforcement Decree of that Act: |
| 2. | Affairs concerning collection and management of information on clinical research on advanced regenerative medicine under Article 19 (2) 4 of the Act; |
| 4. | Affairs concerning receipt of notification of and reporting on the occurrence of adverse reactions under Article 20 (2) of the Act; |
| 5. | Affairs concerning investigation of details of the occurrence of adverse reactions and causes thereof under Article 20 (4) of the Act; |
| 7. | Affairs concerning requests for providing data under Article 22 (1) of the Act and compilation of data under paragraph (3) of that Article. |
| (3) | Where it is inevitable for conducting the following affairs, the head of the Regulatory Science Center may process data including health information referred to in Article 23 (1) of the Personal Information Protection Act, resident registration numbers and alien registration numbers referred to in subparagraphs 1 and 4 of Article 19 of the Enforcement Decree of that Act: |
| 2. | Affairs concerning matters to be complied with by the head of a cell processing facility under Article 18 of the Act; |
| 3. | Affairs concerning matters to be complied with by management entities of human cells, etc. referred to in Article 29 (1) of the Act; |
| (5) | A person who has obtained approval of a clinical trial protocol, a person who has obtained permission by item, or an importer may, if it is inevitable for implementing a plan for a long-term follow-up study and to report on the results of investigation and analysis of adverse events, process health information under Article 23 (1) of the Personal Information Protection Act, or resident registration numbers and alien registration numbers under subparagraphs 1 and 4 of Article 19 of the Enforcement Decree of that Act. |
| (6) | Where it is inevitable for conducting affairs related to personal information of persons to be administered with advanced biological products and registration of records of administration history under Article 30 (4) of the Act, a doctor, dentist, and pharmacist who handles advanced biological products may process data that contain health information under Article 23 (1) of the Personal Information Protection Act, or data containing resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of that Act. |
CHAPTER VII PENALTY PROVISIONS
| Article 44 (Criteria for Imposition of Administrative Fines) |
ADDENDA <Presidential Decree No. 30979, Aug. 27, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on August 28, 2020.
Article 2 (Special Cases concerning Submission of Action Plans including Policy Measures under Jurisdiction)
| (1) | Notwithstanding Article 6 (2), the policy measures, etc. for the sector under jurisdiction which are first prepared after this Decree enters into force shall be submitted by October 31, 2020. |
| (2) | Notwithstanding Article 7 (1), the first action plan to be formulated after this Decree enters into force shall be submitted by November 30, 2020. |
Article 3 Omitted.
Article 4 (Relationship to Other Statutes or Regulations)
Where other statutes or regulations cite the Enforcement Decree of the Pharmaceutical Affairs Act or the provisions thereof as at the time this Decree enters into force, if provisions corresponding thereto exist in this Decree, this Decree or corresponding provisions of this Decree shall be deemed to have been cited.
ADDENDA <Presidential Decree No. 32268, Dec. 28, 2021>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 30, 2021.
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 33112, Dec. 20, 2022>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 33435, Apr. 27, 2023>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 9 Omitted.
ADDENDUM <Presidential Decree No. 33671, Aug. 16, 2023>
This Decree shall enter into force on the date of its promulgation.