CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to contribute to improving the health and quality of life of citizens by establishing a system to secure the safety of advanced regenerative medicine, formulating a scheme for technological innovation and practical use of advanced regenerative medicine, and prescribing matters necessary for securing the quality, safety, and efficacy of advanced biological products and for supporting commercialization thereof.
The terms used in this Act are defined as follows:
| 1. | The term "advanced regenerative medicine" means medical treatment prescribed by Presidential Decree, such as cell therapy, gene therapy, tissue engineering therapy, provided by using human cells, etc. to regenerate, restore, or establish a person's physical structure or function, or to treat or prevent diseases: Provided, That excluded herefrom are operations prescribed by Presidential Decree, which are performed by using simple separation, cleaning, freezing, thawing, or other minimum manipulation of cells or tissues to the extent that their biological properties are maintained; |
| 2. | The term "human cell, etc." means any human cell, tissue, 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: Provided, That excluded herefrom are human tissues defined in subparagraph 1 of Article 3 of the Safety and Management of Human Tissue Act and organs, etc. defined in subparagraph 1 of Article 4 of the Internal Organs Transplant Act; |
| 3. | The term "clinical research of advanced regenerative medicine" means a research on human subjects regarding advanced regenerative medicine for the purposes of improving the quality of life and expand opportunities for treatment of diseases for patients, which is prescribed by Presidential Decree in accordance with the following classification: |
| (a) | Clinical research that has an uncertain impact on, or poses a high risk to, human health and lives; |
| (b) | Clinical research that requires due attention owing to the concern over adverse effects on human health and lives; |
| (c) | Clinical research whose effects on human health and lives are well known, posing minimal risk to human health and lives; |
| 4. | The term "human subject" means a person subject to clinical research of advanced regenerative medicine, who has a critical illness for which no alternative remedy is available or which poses a threat to his or her life, a rare disease under subparagraph 1 of Article 2 of the Rare Disease Management Act, or other incurable diseases, etc; |
| (a) | Cell therapy products: Drugs manufactured through physical, chemical, or biological manipulation, such as in-vitro culturing, multiplying, or selecting of living cells from humans or animals: Provided, That excluded herefrom are those prescribed by Ordinance of the Prime Minister, which are manufactured through minimal manipulation, such as simple separation, cleaning, freezing, and thawing to the extent that biological properties are maintained; |
| (b) | Gene therapy products: Drugs containing genetic material, which are administered to influence the development of genetic material, or drugs containing cells into which altered genetic material is introduced; |
| (c) | Tissue engineering products: Drugs manufactured by applying the engineering technology to the living cells or tissues of humans or animals for the purpose of reproduction, restoration, replacement, etc. of tissues; |
| (d) | Advanced biological combination products: A drug comprised of a physical or chemical combination (including convergence, combination, etc.) between a cell therapy product, gene therapy product, or tissue engineering product and medical devices under Article 2 (1) of the Medical Devices Act: Provided, That excluded herefrom are products whose main function corresponds to a medical device; |
| (e) | Other drugs containing cells, tissues, genetic materials, etc. prescribed by Ordinance of the Prime Minister. |
| Article 3 (Relationship to Other Statutes) |
| Article 4 (Responsibility of the State) |
| (1) | In developing and applying advanced regenerative medical technologies, the State shall make best efforts so that all patients can have easy access to such technology irrespective of their socioeconomic status. |
| (2) | The State shall formulate policies necessary to efficiently address biomedical ethical issues and safety issues that may arise in the course of applying advanced regenerative medicine. |
CHAPTER II FORMULATION OF MASTER PLANS
| Article 5 (Formulation of Master Plans) |
| (1) | The Government shall formulate and implement a master plan for advanced regenerative medicine and advanced biological products (hereinafter referred to as "master plan") every five years to secure the safety and efficacy of advanced regenerative medicine and advanced biological products and to promote research and development and commercialization thereof. |
| (2) | Each master plan shall include the following: |
| 1. | Setting goals and directions of policies; |
| 2. | Plans to improve laws and systems related to advanced regenerative medicine and advanced biological products and to advance the regulation system; |
| 3. | A plan for supporting comprehensive research on ethical, legal, and social meanings and impacts related to advanced regenerative medicine and advanced biological products; |
| 4. | Schemes for supporting the research, development, and commercialization of advanced regenerative medicine and advanced biological products; |
| 5. | Support for clinical research of advanced regenerative medicine; |
| 6. | Schemes for securing and managing the safety and efficacy of advanced regenerative medicine and advanced biological products; |
| 7. | Plans for patient safety management, such as long-term follow-up of clinical research of advanced regenerative medicine and advanced biological products; |
| 9. | Other matters necessary for the support and management of advanced regenerative medicine and advanced biological products. |
| (3) | The Minister of Food and Drug Safety and the heads of the relevant central administrative agencies prescribed by Presidential Decree (hereinafter referred to as "heads of the relevant central administrative agencies") shall formulate policies, etc. regarding the fields under their jurisdiction on the matters referred to in the subparagraphs of paragraph (2) and submit them to the Minister of Health and Welfare. |
| (4) | The Minister of Health and Welfare shall prepare a draft master plan by compiling and coordinating policies, etc. submitted pursuant to paragraph (3) and finalize them subject to deliberation by the Advanced Regenerative Medicine and Advanced Biological Products Policy Committee under Article 7 (1). |
| (5) | The Minister of Health and Welfare shall notify the Minister of Food and Drug Safety and the head of each related central administrative agency of the master plan finalized under paragraph (4). |
| (6) | In formulating a master plan, the Minister of Health and Welfare shall consult in advance with the National Bioethics Committee in accordance with Article 7 of the Bioethics and Safety Act regarding matters that may have a serious social impact in terms of bioethics and safety. |
| (7) | Other matters necessary for formulating and implementing a master plan shall be prescribed by Presidential Decree. |
| Article 6 (Formulation of Action Plans) |
| (1) | The Minister of Health and Welfare, the Minister of Food and Drug Safety, and the heads of the relevant central administrative agencies shall formulate and implement an action plan every year to support and manage advanced regenerative medicine and advanced biological products (hereinafter referred to as "action plan") in accordance with the master plan. |
| (2) | The Minister of Food and Drug Safety and the heads of the relevant central administrative agencies shall submit action plans to the Minister of Health and Welfare every year. |
| (3) | Where necessary to formulate action plans, the Minister of Health and Welfare may prepare basic guidelines necessary for formulating such plans and notify the Minister of Food and Drug Safety and the heads of the relevant central administrative agencies thereof. |
| (4) | Other matters necessary for formulating and implementing action plans shall be prescribed by Presidential Decree. |
| Article 7 (Advanced Regenerative Medicine and Advanced Biological Products Policy Review Committee) |
| (1) | In order to deliberate on the following matters, the Advanced Regenerative Medicine and Advanced Biological Products Policy Committee (hereinafter referred to as "policy committee") shall be established under the Minister of Health and Welfare: |
| 1. | Matters regarding formulating master plans and coordinating the implementation thereof; |
| 2. | Matters regarding inspecting the implementation of a master plan and action plans; |
| 3. | Matters regarding the scope and classification of advanced regenerative medicine, matters subject to approval for and deliberation criteria of clinical research of advanced regenerative medicine, and operation of long-term follow-up; |
| 4. | Matters regarding advanced regenerative medicine implementation institutions under Article 10 and the designation, permission, etc. for advanced regenerative medicine cell processing establishments under Article 15; |
| 5. | Matters regarding fostering and utilizing experts in the field of advanced regenerative medicine and advanced biological products; |
| 6. | Other matters necessary to support and manage the field of advanced regenerative medicine and advanced biological products. |
| (2) | The policy committee shall be composed of up to 21 members including one chairperson and one vice chairperson. |
| (3) | The Minister of Health and Welfare shall be the chairperson, and the Minister of Food and Drug Safety shall be the vice chairperson; and members of the policy committee shall be appointed or commissioned by the Minister of Health and Welfare in consultation with the Minister of Food and Drug Safety, from among the following persons: Provided, That the number of members specified in subparagraph 1 shall not exceed 1/3 of the total number of members: |
| 1. | Vice minister-level public officials of relevant central administrative agencies and heads of relevant public institutions; |
| 2. | Persons who have extensive expert knowledge of and experience in research fields such as bioscience and medical science and the field of advanced regenerative medicine and advanced biological products; |
| 3. | Persons who represent ethics or legal circles, or patients' rights and interests. |
| (4) | Where a member of the policy committee falls under any of the following, he or she shall be disqualified from deliberating on the relevant agenda item subject to deliberation: |
| 1. | Where a member or a corporation or organization, etc. to which a member belongs has direct interest in such agenda item; |
| 2. | Where his or her family (referring to a family provided for in Article 779 of the Civil Act) is a person who has direct interest in such agenda item. |
| (5) | Where the circumstances indicate that it would be impracticable to expect fair deliberation and decisions of a member, any party may file a request for a challenge to the member with the policy committee. In such cases, where the policy committee deems such request reasonable, it shall decide whether to accept the request by resolution. |
| (6) | Where a member of the policy committee falls under paragraph (4) or (5), such member shall recuse himself or herself from deliberation on the relevant agenda item. |
| (7) | Matters necessary for the organization and operation, etc. of the policy committee shall be prescribed by Presidential Decree in addition to the matters specified in paragraphs (1) through (6). |
| Article 8 (Promotion of Industry and Facilitation of Research and Development) |
| (1) | For the purpose of promoting the industry related to advanced regenerative medicine and advanced biological products, the Government shall encourage research and development activities and the development of new technology, and formulate and implement policies for fostering the relevant industry. |
| (2) | In order to efficiently develop and foster technologies relating to advanced regenerative medicine and advanced biological products, the Government shall endeavor to expand investment in research and development, and shall facilitate the formation of a consultative body among academia, research institutes, and industry and promote joint research. |
| (3) | The Minister of Health and Welfare and the Minister of Food and Drug Safety shall collect and investigate information on research and development in Korea and abroad, such as research and development trends in Korea and overseas and market trends, and manage and disseminate such information in a systematic and comprehensive manner. |
| Article 9 (Establishment and Designation of Advanced Regenerative Medicine Support Institutions) |
| (1) | To efficiently and systematically implement programs for promoting advanced regenerative medical technologies and to support the development of relevant policies to ensure safety thereof, the Minister of Health and Welfare may establish an advanced regenerative medicine support institution (hereinafter referred to as "support institution") or designate an institution, organization, or corporation deemed capable of performing the relevant business as a support institution. |
| (2) | A support institution shall conduct the following programs: |
| 1. | Research, survey, and planning of policies and systems for promoting advanced regenerative medical technologies and securing safety thereof; |
| 2. | Planning the development of technology necessary for the promotion of advanced regenerative medical technologies and the management of and advice on developed technologies; |
| 3. | Training and support of experts related to advanced regenerative medicine; |
| 4. | Support for creating infrastructure for the industries related to advanced regenerative medicine and strengthening such infrastructure; |
| 5. | International exchange, cooperation, and support in the field of advanced regenerative medicine; |
| 6. | Other programs necessary for achieving the purpose of the support institution. |
| (3) | The Government may contribute money or provide subsidy to cover expenses required for the establishment, operation, etc. of a support institution within the budget. |
| (4) | Other matters necessary for the operation, etc. of a support institution shall be prescribed by Presidential Decree. |
CHAPTER III IMPLEMENTATION OF CLINICAL RESEARCH OF ADVANCED REGENERATIVE MEDICINE AND SAFETY MANAGEMENT THEREOF
| Article 10 (Advanced Regenerative Medicine Implementation Institutions) |
| (1) | A medical institution under Article 3 of the Medical Service Act (hereinafter referred to as "medical institution") that intends to conduct clinical research of advanced regenerative medicine shall be designated as an advanced regenerative medicine implementation institution by the Minister of Health and Welfare. |
| (2) | A person who intends to be designated as an advanced regenerative medicine implementation institution pursuant to paragraph (1) shall have facilities, equipment, human resources, etc. prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | Where a person designated as an advanced regenerative medicine implementation institution pursuant to paragraph (1) (hereinafter referred to as "regenerative medical institution") conducts clinical research of advanced regenerative medicine, he or she shall do so with human cells, etc. supplied by an advanced regenerative medicine cell processing establishment under Article 15: Provided, That where an a regenerative medical institution conducts clinical research of advanced regenerative medicine falling under subparagraph 3 (c) of Article 2, it may use human cells, etc. processed by the relevant regenerative medical institution, as prescribed by Ordinance of the Ministry of Health and Welfare. |
| (4) | An institution for advanced regenerative medicine shall record, manage, and keep matters regarding clinical research of advanced regenerative medicine, as prescribed by Ordinance of the Ministry of Health and Welfare, report its records to the head of the advanced regenerative medicine safety management institution prescribed in Article 19, and comply with good practices for conducting clinical research of advanced regenerative medicine prescribed by Presidential Decree. |
| (5) | No regenerative medical institution shall charge any human subject for expenses incurred in the clinical research of advanced regenerative medicine. |
| (6) | Where the designation of a regenerative medical institution is revoked pursuant to Article 42, the regenerative medical institution shall report matters regarding the processing and storage, etc. of human cells, etc. to the Minister of Health and Welfare. |
| (7) | A human subject may request the relevant regenerative medical institution to disclose information about him or her, and the institution so requested shall disclose relevant information, in the absence of good cause. |
| (8) | Matters necessary for the designation of a regenerative medical institution, the procedures and methods for reporting or disclosing information on processing, storage, etc. of human cells, etc. under paragraphs (1), (6), and (7) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 11 (Consent to Clinical Research of Advanced Regenerative Medicine) |
| (1) | Each regenerative medical institution shall obtain signature on a written consent describing the following matters from the human subject before conducting clinical research of advanced regenerative medicine: |
| 1. | Objectives and details of the clinical research of advanced regenerative medicine; |
| 2. | Expected results of and adverse reactions to the clinical research of advanced regenerative medicine; |
| 3. | Compensation for losses incurred in the participation in the clinical research of advanced regenerative medicine; |
| 4. | Matters regarding protection and provision of personal information; |
| 5. | Matters regarding withdrawal of consent; |
| 6. | Matters regarding follow-up measures, such as notifying adverse reactions and long-term follow-up; |
| 7. | Other matters prescribed by Ordinance of the Ministry of Health and Welfare regarding consent to clinical research of advanced regenerative medicine. |
| (2) | Notwithstanding paragraph (1), where a human subject is a minor, the person shall obtain the consent of the principal and his or her parents (referring to his or her legal representative if he or she has no parent), and where the principal is a person who is incapable of, or incompetent for, giving consent, the written consent of the following representatives shall be obtained: In such cases, the consent of the representative shall not be contrary to the intention of the human subject: |
| 1. | The legal representative; |
| 2. | If no legal representative is appointed, the spouse or a lineal ascendant or descendant shall act as a representative for such person in the abovementioned order; but if there are two or more lineal ascendants or descendants, the representative for such person shall be appointed under agreement by and between such ascendants or descendants, or the oldest person among them shall act as the representative for such person if they fail to reach an agreement. |
| (3) | A regenerative medical institution shall fully explain matters specified in the subparagraphs of paragraph (1) to the human subject before obtaining consent pursuant to paragraph (1). |
| (4) | A regenerative medical institution shall purchase insurance to cover any loss or damages that may occur to human subjects; and where it compensates for any damage that arises, it shall observe the procedures, etc. for compensation that has been explained to human subjects in advance. |
| (5) | Matters necessary for the methods, procedures, etc. for obtaining consent under paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 12 (Deliberation on and Approval of Protocols for Clinical Research of Advanced Regenerative Medicine) |
| (1) | Where a regenerative medical institution intends to conduct clinical research of advanced regenerative medicine, it shall prepare a protocol to conduct such research (hereinafter referred to as "protocol for clinical research of advanced regenerative medicine"), as prescribed by Presidential Decree, and undergo deliberation thereon by the Advanced Regenerative Medicine and Advanced Biological Products Policy Committee under Article 13 (1) (hereinafter referred to as "review committee”). |
| (2) | The Minister of Health and Welfare or the Minister of Food and Drug Safety shall notify the regenerative medical institution of the results of the review by the review committee on whether the protocol for clinical research of advanced regenerative medicine is adequate, and the regenerative medical institution notified of the adequacy may conduct clinical research of advanced regenerative medicine. |
| (3) | Notwithstanding paragraphs (1) and (2), a regenerative medical institution shall obtain approval from the Minister of Food and Drug Safety after undergoing deliberation by the review committee under paragraph (1) before conducting clinical research of advanced regenerative medicine falling under subparagraph 3 (a) of Article 2. In such cases, due regard shall be given to whether there is no available therapy at present or whether it constitutes a therapy expected to show remarkable efficacy compared to other therapies. |
| (4) | Where a protocol for clinical research of advanced regenerative medicine has been deliberated by the review committee, it shall be deemed to have been deliberated by an institutional review board under Article 10 of the Bioethics and Safety Act. |
| (5) | Other matters necessary for, among other things, the procedures for and methods of the deliberation and approval for protocols for clinical research of advanced regenerative medicine shall be prescribed by Presidential Decree. |
| Article 13 (Advanced Regenerative Medicine and Advanced Biological Products Review Committee) |
| (1) | The Minister of Health and Welfare and the Minister of Food and Drug Safety shall establish the Advanced Regenerative Medicine and Advanced Biological Products Review Committee under their joint jurisdiction for the purposes of deliberating on protocols for clinical research of advanced regenerative medicine and advising on the evaluation of advanced biological products. |
| (2) | The review committee shall be comprised of up to 20 persons, including one chairperson, who are appointed or commissioned by the Minister of Health and Welfare in consultation with the Minister of Food and Drug Safety, from among the following persons, and the vice chairperson shall be elected by and from among its members: |
| 1. | Medical personnel with extensive knowledge of and experience in the field of advanced regenerative medicine and advanced biological products; |
| 2. | Persons who have extensive knowledge of and experience in research fields, such as molecular biology, cell biology, genetics, toxicology, clinical pharmacology, immunology, or pathology; |
| 3. | A person who can deliberate on social and ethical validity related to advanced regenerative medicine or advanced biological products or person who can represent patients. |
| (4) | The review committee may establish subcommittees by field based on the methods of clinical research of advanced regenerative medicine, kinds of human cells, etc. |
| (5) | A secretariat may be established in the review committee in order to handle the affairs thereof. |
| (6) | Except as provided in paragraphs (1) through (5), matters necessary for the organization, etc. of the review committee and its subcommittees shall be prescribed by Presidential Decree. |
| Article 14 (Operation of Review Committee) |
| (1) | The review committee shall deliberate and resolve on the following matters: |
| 1. | Whether the protocol for clinical research of advanced regenerative medicine is adequate; |
| 2. | Whether to conduct a long-term follow-up under Article 21 after clinical research of advanced regenerative medicine; |
| 3. | Other matters prescribed by Presidential Decree. |
| (2) | Where the review committee deliberates on the adequacy of a protocol for clinical research of advanced regenerative medicine under paragraph (1) 1, it shall take into account the following: |
| 1. | Scientific and ethical validity, urgency, and necessity of the research; |
| 2. | Adequacy of the selection and number of human subjects and the period of research; |
| 3. | Adequacy of measures for securing the safety of human subjects; |
| 4. | Other matters prescribed by Presidential Decree. |
| (3) | Where the review committee holds a meeting for deliberation under paragraph (1), it shall prepare and disclose meeting minutes stating the date, time, venue, members present, outcomes of deliberation, etc.: Provided, That in special circumstances prescribed by Presidential Decree, such as a substantial detriment to the rights of a researcher or a human subject or public interest, the meeting minutes need not be disclosed. |
| (4) | The Minister of Food and Drug Safety may request the review committee to provide professional and technical advice on the following: |
| 1. | Matters regarding safety management, such as long-term follow-up of advanced biological products under Article 30; |
| 2. | Classification of items to which advanced biotechnology is applied under Article 35; |
| 3. | Matters regarding the designation of advanced biological products subject to fast-track processing referred to in Article 36; |
| 4. | Matters regarding the evaluation of the quality, safety, and efficacy of advanced biological products; |
| 5. | Other matters necessary for evaluating advanced biological products. |
| (5) | Article 7 (4) through (6) shall apply mutatis mutandis to the exclusion of, challenge to, or recusal of, a member of the review committee. |
| (6) | Other matters necessary to operate the review committee shall be prescribed by Presidential Decree. |
| Article 15 (Advanced Regenerative Medicine Cell Processing Establishments) |
| (1) | A person who intends to engage in the business of recovering, examining, processing, and supplying human cells, etc. to a regenerative medical institution (hereinafter referred to as "cell processing business") shall obtain permission for an advanced regenerative medicine cell processing establishment from the Minister of Food and Drug Safety after being equipped with facilities, human resources, and equipment prescribed by Presidential Decree. The same shall also apply to the modification of permitted matters. |
| (2) | Entities that are eligible for permission for cell processing establishments under paragraph (1) shall be as prescribed in the following subparagraphs: |
| 1. | The State or a local government; |
| 6. | A corporation established with the main purpose of engaging in a business relating to cell processing; |
| 7. | Other institutions specified by Presidential Decree. |
| (3) | Notwithstanding paragraph (1), a person who has obtained permission for a management business of human cells, etc. pursuant to Article 28 (1) (including cases where a person is deemed to have obtained permission pursuant to paragraph (2) of the same Article) shall be deemed to have obtained permission under paragraph (1) if he or she has filed a notification with the Minister of Food and Drug Safety. |
| (4) | The head of a cell processing establishment shall record and keep matters regarding cell processing business as prescribed by Presidential Decree and report regularly to the head of the advanced regenerative medicine safety management institution referred to in Article 19. |
| (5) | Where the head of a cell processing establishment intends to close or suspend the business or resume the suspended business, he or she shall notify the Minister of Food and Drug Safety thereof within seven days: Provided, That if the period of suspension of business is less than one month, no notification need be filed. |
| (6) | The head of a cell processing establishment shall renew his or her permit every three years, as prescribed by Presidential Decree. |
| Article 16 (Recovery of Human Cells) |
| (1) | Where the head of a cell processing establishment intends to recover human cells, etc., he or she shall require a medical doctor to directly recover them at a medical institution or a medical personnel, other than the medical doctors defined in Article 2 of the Medical Service Act, to recover them under the supervision of a medical doctor. |
| (2) | When recovering human cells, etc. pursuant to paragraph (1), a medical personnel shall recover them in a way that does not undermine the health of human subjects and donors of human cells, etc. |
| (3) | A medical personnel shall obtain a written consent regarding the following matters from the person subject to recovery before recovering human cells, etc.: |
| 1. | Matters regarding the purpose and methods of recovering human cells, etc.; |
| 2. | Matters regarding protection and processing of personal information; |
| 3. | Matters regarding the examination, confirmation, etc. of medical history to determine whether human cells, etc. are appropriate for clinical research of advanced regenerative medicine; |
| 4. | Matters regarding the provision, preservation, and destruction of human cells, etc.; |
| 5. | Withdrawal of consent and other matters specified by Ordinance of the Ministry of Health and Welfare. |
| (4) | Notwithstanding paragraph (3), where a person subject to recovery of human cells, etc. is a minor, the consent shall be obtained from the principal and his or her parents (referring to his or her legal representative if he or she has no parent), and where the principal is a person who is incapable of, or incompetent for, giving consent, the written consent shall be obtained from the following representatives: In such cases, the recovery of human cells, etc. from a person who is incapable of, or incompetent for, giving consent shall be limited to where the recovery is for treating the principal: |
| 1. | The legal representative; |
| 2. | If no legal representative is appointed, the spouse or a lineal ascendant or descendant shall act as a representative for such person in the abovementioned order; but if there are two or more lineal ascendants or descendants, the representative for such person shall be appointed under agreement by and between such ascendants or descendants, or the oldest person among them shall act as the representative for such person if they fail to reach an agreement. |
| (5) | A person subject to recovery who consents to the recovery of human cells, etc. pursuant to paragraphs (3) and (4), his or her legal representative or family member shall provide personal information and information on medical history necessary for verifying the safety of the human cells, etc., in good faith and based on facts. |
| (6) | Xenogenic cells, tissues to extract xenogenic cells, and xenogenic organs may be recovered even by a person who is not a medical personnel at an animal testing institution defined in subparagraph 5 of Article 2 of the Animal Protection Act, as prescribed by Presidential Decree. |
| (7) | The details of, and the procedures for, consent under paragraphs (3) and (4) and other necessary matters shall be prescribed by Presidential Decree. |
| Article 17 (Entrustment of Cell Processing Business) |
| (1) | The head of a cell processing establishment may entrust all or some of cell processing business to medical institutions and other institutions prescribed by Presidential Decree. |
| (2) | Pursuant to paragraph (1), no cell processing establishment shall entrust cell processing business to institutions other than those prescribed by Presidential Decree. |
| (3) | Matters necessary for the scope of entrustment of cell processing business, the procedures for and methods of entrustment, the revocation of entrustment, etc. shall be prescribed by Presidential Decree. |
| Article 18 (Matters to be Observed by Heads of Cell Processing Establishments) |
The head of a cell processing establishment shall comply with the matters prescribed by Ordinance of the Ministry of Health and Welfare, such as the establishment and management of quality and safety standards necessary in the course of recovering, processing, and storing human cells, etc.
| Article 19 (Advanced Regenerative Medicine Safety Management Institutions) |
| (1) | To ensure the safety of advanced regenerative medicine, the Minister of Health and Welfare shall designate an advanced regenerative medicine safety management institution to perform safety management duties (hereinafter referred to as "safety management institution") among the institutions affiliated with the Ministry of Health and Welfare or the Korea Disease Control and Prevention Agency. <Amended on Aug. 11, 2020> |
| (2) | A safety management institution shall perform the following affairs: |
| 1. | Management and supervision of regenerative medical institutions; |
| 2. | Establishment of a follow-up system to investigate the causes of adverse reactions after clinical research of advanced regenerative medicine; |
| 3. | Receiving reports on clinical research of advanced regenerative medicine referred to in Article 10 (4); |
| 4. | Collecting and managing information on clinical research of advanced regenerative medicine; |
| 5. | Receiving reports on cell processing business under Article 15 (4); |
| 6. | Receipt of reports or notifications on adverse reactions and investigations following such reports or notifications under Article 20; |
| 8. | Other affairs prescribed by Presidential Decree as necessary for the safety and management of advanced regenerative medicine. |
| (3) | A safety management institution and a regulatory science center for advanced biological products under Article 32 shall establish an administrative and institutional cooperation system to facilitate sharing of information on advanced regenerative medicine and advanced biological products. |
| (4) | Matters necessary for, among other things, the procedures for and methods of conducting affairs by a safety management institution under paragraphs (2) and (3) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 20 (Safety Monitoring and Reporting on Adverse Reactions) |
| (1) | The head of a safety management institution shall continuously conduct safety monitoring to collect and analyze the current status and trends of the occurrence of adverse reactions, in relation to clinical research of advanced regenerative medicine, as prescribed by Ordinance of the Ministry of Health and Welfare, and report the results thereof to the Minister of Health and Welfare. |
| (2) | Upon finding the occurrence of an adverse reaction in a human subject or upon receiving a notification from a human subject pursuant to paragraph (3) after clinical research of advanced regenerative medicine, a regenerative medical institution shall report it to the head of a safety management institution without delay. |
| (3) | Where a human subject suspects any adverse reaction caused by clinical research of advanced regenerative medicine, he or she shall notify the head of a regenerative medical institution or safety management institution thereof. |
| (4) | Upon receipt of a report or notification under paragraph (2) or (3), the head of a safety management institution shall immediately investigate the causes and events leading to the adverse reactions. |
| (5) | Matters necessary for the methods of and procedures for reporting, notifying, and investigating adverse reactions under paragraphs (2) through (4) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 21 (Long-Term Follow-Up of Clinical Research of Advanced Regenerative Medicine) |
| (1) | The head of a safety management institution shall conduct a long-term follow-up of clinical research of advanced regenerative medicine where deemed necessary based on deliberation and resolution by the review committee. |
| (2) | When a long-term follow-up under paragraph (1) is conducted, human subjects and the regenerative medical institution shall comply with the instructions of the head of a safety management institution. In such cases, the Government may subsidize the expenses incurred in following such instructions. |
| (3) | Upon completing a long-term follow-up under paragraph (1), the head of a safety management institution shall report the result thereof to the Minister of Health and Welfare. |
| (4) | Where necessary based on results of a long-term follow-up, The Minister of Health and Welfare may take measures necessary for public health with regard to regenerative medical institutions, such as the suspension of clinical research of advanced regenerative medicine and the preparation of measures to protect patients, etc., as prescribed by Presidential Decree. |
| (5) | Matters necessary for details and methods, etc. of a long-term follow-up under paragraph (1) shall be prescribed by Presidential Decree. |
| Article 22 (Requests to Provide Data) |
| (1) | Where deemed necessary to perform his or her duties for the purposes of a long-term follow-up under Article 21, the head of a safety management institution may request the following institutions or persons to submit relevant data. In such cases, an institution or a person in receipt of the request to submit data shall comply therewith, in the absence of good cause: |
| 1. | The State or a local government; |
| 2. | Public institutions or public organizations; |
| 4. | A pharmacy founder or a medical institution founder; |
| 5. | The head of a cell processing establishment. |
| (2) | Where the head of a safety management institution requests necessary data under paragraph (1), he or she may request data that include personal information, such as sensitive information under Article 23 of the Personal Information Protection Act and personally identifiable information (including resident registration numbers) under Article 24 of the same Act. In such cases, an institution or a person in receipt of such request shall provide the data after deleting personally identifiable information. |
| (3) | Notwithstanding paragraph (2), where the Minister of Health and Welfare approves that data held by at least two institutions or persons need to be consolidated for analysis, the head of the safety management institution may receive and consolidate data including personally identifiable information. In such cases, upon consolidating the data, he or she shall, without delay, delete personally identifiable information to prevent its recovery or restoration. |
| (4) | The head of a safety management institution shall provide data received pursuant to paragraph (1) upon request of the Minister of Food and Drug Safety. |
| (5) | Data provided under paragraphs (1) through (3) shall not be used for purposes other than originally intended. |
CHAPTER IV PERMISSION FOR AND SAFETY MANAGEMENT OF ADVANCED BIOLOGICAL PRODUCTS
| Article 23 (Permission for Manufacturing Advanced Biological Products) |
| (1) | A person who intends to engage in the business of manufacturing advanced biological products shall have necessary facilities in accordance with standards prescribed by Presidential Decree and obtain permission from the Minister of Food and Drug Safety. In such cases, a person who has obtained permission for a manufacturing business (hereinafter referred to as "manufacturer") shall be deemed a manufacturer who has obtained permission pursuant to Article 31 (1) of the Pharmaceutical Affairs Act only with respect to advanced biological products. |
| (2) | Where a manufacturer intends to distribute advanced biological products manufactured (including where the manufacture is entrusted to another manufacturer), he or she shall submit the following data and obtain permission for manufacturing and distributing each item (hereinafter referred to as "permission by item"). In such cases, a person who has obtained permission by item shall be deemed a person who has obtained permission by item pursuant to Article 31 (2) of the Pharmaceutical Affairs Act: |
| 1. | Data on safety and efficacy; |
| 2. | Data on standards for manufacture and quality control and data on testing methods; |
| 3. | Data necessary for evaluating the status of implementation of the standards for manufacture and quality control; |
| 4. | Risk management plans for the safe use of advanced biological products; |
| 5. | Data necessary for obtaining permission or authorization or filing a notification, such as technical documents of a medical device and clinical trial data prescribed in the Medical Devices Act, with respect to a medical device constituting a part of an advanced biological product: Provided, That where a manufacturer has obtained permission or authorization for the relevant medical device or filed a notification thereon pursuant to the Medical Devices Act, a permit, certificate, or a notification receipt may be used in lieu thereof; |
| 6. | Other data necessary for permission and safety management as prescribed by Presidential Decree. |
| (3) | Where any person, other than a manufacturer, intends to distribute advanced biological products after outsourcing their manufacturing to a manufacturer, he or she shall file a notification of a contract manufacturing and distribution business with the Minister of Food and Drug Safety and obtain permission by item. In such cases, a person who has filed a notification of a contract manufacturing and distribution business shall be deemed a person who has filed a notification of a contract manufacturing and distribution business pursuant to Article 31 (3) of the Pharmaceutical Affairs Act only with respect to advanced biological products, and a person who has obtained permission by item shall be deemed a person who has obtained permission by item pursuant to Article 31 (3) of the Pharmaceutical Affairs Act. |
| (4) | A person who has obtained permission by item pursuant to paragraphs (2) and (3) may establish a place of business, as prescribed by Ordinance of the Prime Minister. |
| (5) | Notwithstanding paragraphs (1) through (3), a manufacturing business permission or permission by item need not be obtained for advanced biological products prescribed by Ordinance of the Prime Minister, such as advanced biological products for clinical trials. |
| (6) | None of the following persons may obtain permission for or file a notification of a manufacturing business or contract manufacturing and distribution business of advanced biological products: |
| 2. | A person under adult guardianship or person under limited guardianship; |
| 3. | An addict of narcotics, hemp or other anti-psychotic drugs; |
| 5. | A person for whom three years have not elapsed since his or her license was revoked for committing the crimes under Article 347 of the Criminal Act or for whom two years have not elapsed since his or her license was revoked for violating the statutes and regulations governing pharmaceutical affairs; |
| 6. | A person for whom one year has not elapsed since the revocation of permission for manufacturing business or the closure of a contract manufacturing business office under Article 42 or the Pharmaceutical Affairs Act: Provided, That the same shall not apply to any of the following cases: |
| (a) | A person recognized as capable of performing pharmaceutical affairs by a psychiatrist after being subject to the revocation of permission for manufacturing business or the closure of a contract manufacturing business office as he or she falls under subparagraph 1 or 3; |
| (b) | A person determined for termination of adult guardianship or limited guardianship by a family court after being subject to the revocation of permission for manufacturing business or the closure of a contract manufacturing business office as he or she falls under subparagraph 2. |
| 7. | A person who has been declared bankrupt, and is not yet reinstated. |
| (7) | When a person intends to modify any matter prescribed by Ordinance of the Prime Minister among the matters permitted or notified pursuant to paragraphs (1) through (3), he or she shall obtain permission for such modification or file a notification on such modification. In such cases, a person who has obtained permission for, or filed a notification on, modification shall be deemed a person who has obtained permission for, or filed a notification on modification pursuant to Article 31 (9) of the Pharmaceutical Affairs Act. |
| (8) | A person who has obtained permission to manufacture advanced biological products or has filed a notification of a contract manufacturing and distribution business shall renew the permit or certificate of notification every three years, as prescribed by Ordinance of the Prime Minister. |
| (9) | Upon receipt of a notification under the latter part of paragraph (3) or (7), the Minister of Food and Drug Safety shall review the details of the notification and accept it if such notification is in compliance with this Act. |
| (10) | Matters necessary for subjects, standards, procedures, and methods for manufacturing business permission, permission by item, filing a notification of a contract manufacturing and distribution business under paragraphs (1) through (3), and procedures, methods, etc. for permission for modification and notifying modification under paragraph (7) shall be prescribed by Ordinance of the Prime Minister. |
| Article 24 (Manufacturing Managers of Advanced Biological Products) |
| (1) | Each manufacturer shall assign such number of pharmacists or oriental medicine pharmacists as is required by Ordinance of the Prime Minister in each of his or her factory, and have them manage the manufacturing of advanced biological products: Provided, That in the case of the manufacturing business of cell therapy products or gene therapy products, a medical doctor approved by the Minister of Food and Drug Safety or a professional engineer with expertise prescribed by Ordinance of the Prime Minister may be required to manage the manufacturing business. |
| (2) | Where a manufacturer assigns a person to be in charge of managing the manufacturing of advanced biological products (hereinafter referred to as "manufacturing manager") pursuant to paragraph (1), he or she shall notify the Minister of Food and Drug Safety thereof, as prescribed by Ordinance of the Prime Minister. |
| (3) | Upon receipt of a notification under paragraph (2), the Minister of Oceans and Fisheries shall review the details of the notification and accept it if such notification is consistent with this Act. |
| Article 25 (Duty to Manage Manufacturing of Advanced Biological Products) |
| (1) | A manufacturing manager shall comply with Ordinance of the Prime Minister with respect to the guidance and supervision over employees engaged in the manufacturing of advanced biological products, quality control, the management of manufacturing facilities, and other matters regarding the management of manufacturing advanced biological products. |
| (2) | No manufacturing manager shall engage in affairs, other than management of manufacturing in the relevant factory. |
| (3) | No manufacturer or person who has obtained permission by item shall obstruct the management of manufacturing by a manufacturing manager, nor refuse, without good cause, any request from a manufacturing manager for matters necessary for performing the duties of a manufacturing manager. |
| Article 26 (Duties of Manufacturing Advanced Biological Products, Quality Control, and Reporting) |
| (1) | A manufacturer or a person who has obtained permission by item shall comply with the following matters regarding manufacturing and quality control: |
| 1. | No human cells, etc. recovered from persons prescribed by Ordinance of the Prime Minister, including persons with infectious diseases, such as hepatitis B, hepatitis C, syphilis, and acquired immune deficiency syndrome, shall be used for the manufacture of advanced biological products: Provided, That the same shall not apply where human cells, etc. are intended to be recovered from the person who will be administered with the biological product to manufacture advanced biological products; |
| 2. | Quality and safety standards for human cells, etc. shall be determined as prescribed by Ordinance of the Prime Minister; and human cells, etc. may be used for manufacturing only when they are in compliance with such standards; |
| 3. | Facilities of a factory shall be managed in a sanitary manner in order to prevent any risk to public health and sanitation; |
| 4. | Any necessary testing and inspection or examination shall be conducted thoroughly from the warehousing of raw materials and other materials to the release of finished products; |
| 5. | Observing other matters prescribed by Presidential Decree with respect to manufacture and quality control. |
| (2) | A person who has obtained permission by item shall report the performance of production and export of advanced biological products to the Minister of Food and Drug Safety or the president of the Korea Pharmaceutical Information Service established under Article 47-3 (1) of the Pharmaceutical Affairs Act. |
| Article 27 (Import License for Advanced Biological Products) |
| (1) | A person who intends to engage in the business of importing advanced biological products shall file a notification of an import business with the Minister of Food and Drug Safety and obtain permission for each item. The same shall apply to any revision to reported or permitted matters. |
| (2) | A person who has filed a notification of an import business under paragraph (1) (hereinafter referred to as "importer") shall be deemed an importer who has filed a notification pursuant to the former part of Article 42 (1) of the Pharmaceutical Affairs Act only with respect to advanced biological products; a person who has obtained permission by item, a person who has obtained permission by item under the former part of Article 42 (1) of the Pharmaceutical Affairs Act; and a person who has filed a notification of modification or obtained permission for modification, a person who has filed a notification of modification or obtained permission for modification under the latter part of Article 42 (1) of the Pharmaceutical Affairs Act. |
| (3) | An importer shall be equipped with necessary facilities, such as business places, in compliance with the standards for facilities prescribed by Presidential Decree. |
| (4) | None of the following persons may file a notification of an import business under paragraph (1). The same shall apply to a corporation if the corporation has any of the following persons as representative: |
| 1. | A person who falls under any subparagraph of Article 23 (6) (excluding subparagraph 6); |
| 2. | A person for whom one year has not passed since a business place is closed pursuant to Article 42: Provided, That the same shall not apply to any of the following cases: |
| (a) | A person recognized as capable of performing pharmaceutical affairs by a psychiatrist after being subject to closure of a place of business for falling under subparagraph 1 or 3 of Article 23 (6); |
| (b) | A person determined for termination of adult guardianship or limited guardianship by a family court after being subject to closure of a place of business for falling under Article 23 (6) 2. |
| (5) | Article 23 (2) and (8) and Articles 24 through 26 shall apply mutatis mutandis to advanced biological products imported under paragraph (1) and importers thereof. In such cases, "manufacture" or "production" shall be construed as "import," "manufacturer" or "person who has obtained permission by item" as "importer," and "factory or contract manufacturing business office" as "place of business," respectively. |
| (6) | Upon receipt of a notification under paragraph (1), the Minister of Food and Drug Safety shall review the details of the notification and accept it if such notification is in compliance with this Act. |
| (7) | Where an importer intends to import advanced biological products for which he or she has obtained permission by item pursuant to paragraph (1), he or she shall register matters prescribed by Ordinance of the Prime Minister, such as the name and location of the relevant overseas factory (referring to an establishment located overseas in which manufacturing and quality control is conducted), with the Minister of Food and Drug Safety. |
| (8) | An importer who intends to modify any matter prescribed by Ordinance of the Prime Minister, among the matters registered pursuant to paragraph (7), shall file for registration of modification with the Minister of Food and Drug Safety; and where the importer modifies matters other than those prescribed by Ordinance of the Prime Minister, he or she shall file a notification of such modification with the Minister of Food and Drug Safety. |
| (9) | Matters necessary for the subjects, criteria, procedures and methods of a notification of an import business, permission by item, and permission for modification under paragraph (1) and for procedures and methods of registration, registration of modification, and notification of modification under paragraphs (7) and (8) shall be prescribed by Ordinance of the Prime Minister. |
| Article 28 (Permission of Management Business of Human Cells) |
| (1) | Any person who intends to engage in a business of supplying human cells, etc. as raw materials for advanced biological products (hereinafter referred to as "business of managing human cells, etc.") by recovering, importing, examining and processing human cells, etc. shall have facilities, equipment, human resources, and quality control systems prescribed by Presidential Decree and obtain permission from the Minister of Food and Drug Safety. The same shall apply to the modification of permitted matters. |
| (2) | Notwithstanding paragraph (1), permission under paragraph (1) shall be deemed obtained in any of the following cases: |
| 1. | Where a manufacturer engages in the business of managing human cells, etc. to manufacture the manufacturer's advanced biological products; |
| (3) | Where a person who has obtained permission under paragraph (1) (hereinafter referred to as "human cell management business entity") intends to close, suspend, or resume business, he or she shall notify the Minister of Food and Drug Safety of the fact within seven days: Provided, That notification need not be made where the period of business suspension is less than one month. |
| (4) | A human cell management business entity shall renew his or her permit every three years: Provided, That with respect to cases deemed to have obtained permission pursuant to paragraph (2), the Minister of Food and Drug Safety shall verify every three years whether the relevant person falls under the subparagraphs of paragraph (2). |
| (5) | Articles 16 and 17 shall apply mutatis mutandis to the recovery of human cells, etc. by a human cell management business entity and the entrustment of the business of managing human cells, etc., etc. In such cases, "human subject" shall be construed as "human subject of a clinical trial." |
| (6) | Matters necessary for permission for, permission for modification of, notification of, renewal of permission for, a management business of human cells, etc. under paragraphs (1), (3) and (4) shall be prescribed by Ordinance of the Prime Minister. |
| Article 29 (Matters to Be Observed by Human Cell Management Business Entities) |
| (1) | In order to prevent and control the spread, etc. of infectious diseases by advanced biological products, every human cell management business entity shall observe the following matters: |
| 1. | A human cell management business entity shall establish and manage quality and safety standards necessary in the process of recovering, importing, processing, and storing human cells, etc., as prescribed by Ordinance of the Prime Minister; |
| 2. | A human cell management business entity shall assess whether human cells, etc. are suitable as raw materials for advanced biological products by examining the medical history of the donor and conducting blood tests and microbiological tests, as prescribed by Ordinance of the Prime Minister; |
| 3. | When supplying human cells, etc. to a manufacturer of advanced biological products, a human cell management business entity shall furnish information enabling the tracing of donors, along with the assessment results referred to in subparagraph 2; |
| 4. | A human cell management business entity shall observe matters prescribed by Ordinance of the Prime Minister to ensure the quality and safety of human cells, etc. |
| (2) | A human cell management business entity shall prepare and keep records on the business of managing human cells, etc. |
| (3) | No human cell management business entity shall provide any other person with the health information of donors of human cells, etc., test results under paragraph (1) 2, and the like: Provided, That the same shall not apply to cases prescribed by Ordinance of the Prime Minister, such as where such information or test results are necessary to manufacture and administer advanced biological products. |
| (4) | Standards for quality and safety of human cells, etc. and the preparation and keeping of records under paragraphs (1) and (2) and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 30 (Registration of Long-Term Follow-Up, and Details of Administration, of Advanced Biological Products) |
| (1) | The Minister of Food and Drug Safety may designate advanced biological products including stem cells or animal cells or tissues, as advanced biological products subject to a long-term follow-up if it is deemed necessary to confirm whether any adverse reactions occur over a certain period after administer them. |
| (2) | A person who has obtained approval for a clinical trial protocol under Article 34 (1) of the Pharmaceutical Affairs Act (hereinafter referred to as "person who has obtained approval for a clinical trial protocol"; and limited to a person who has obtained approval for advanced biological products); a person who has obtained permission by item for advanced biological products or an importer thereof shall formulate a long-term follow-up plan as prescribed by Ordinance of the Prime Minister. |
| (3) | Where a person who has obtained approval for a clinical trial protocol, a person who has obtained permission by item for advanced biological products, and an importer thereof become aware of the occurrence of a serious adverse event in a patient administered with an advanced biological product subject to a long-term follow-up while implementing a long-term follow-up plan formulated under paragraph (2), they shall investigate and analyze the adverse event and report it to the Minister of Food and Drug Safety. |
| (4) | Medical doctors, dentists, and pharmacists handling an advanced biological product subject to long-term follow-up prescribed in paragraph (1) shall register the personal information of a person administered with such biological product and details of administration with a regulatory science center for advanced biological products under Article 32 (1), with the consent of the person, as prescribed by Presidential Decree. |
| (5) | A person who has obtained approval for a clinical trial protocol, a person who has obtained permission by item for advanced biological products, and an importer thereof shall register the details of the sale and supply of such advanced biological products subject to long-term follow-up as designated pursuant to paragraph (1) with a regulatory science center for advanced biological products referred to in Article 32 (1). |
| (6) | The Minister of Food and Drug Safety may take measures necessary for public health prescribed by Presidential Decree, such as the suspension of clinical trials, the suspension of manufacture, import or sale of the relevant items, and an order for recall and destruction with respect to a person who has obtained approval for a clinical trial protocol, a person who has obtained permission by item for advanced biological products, an importer thereof, and others. |
| (7) | Matters necessary for, among other things, the scope of, and the procedures for and methods of, long-term follow-up under paragraph (1), the methods of reporting an adverse event under paragraph (3), the procedures for obtaining consent and the methods of registration under paragraph (4), the methods of registration under paragraph (5) shall be prescribed by Presidential Decree. |
| Article 31 (Labeling on Containers of Advanced Biological Products) |
A person who has obtained permission by item for advanced biological products and an importer thereof shall state the information prescribed in the subparagraphs of Article 56 (1) of the Pharmaceutical Affairs Act and the information prescribed in the following subparagraphs on the containers or packages of advanced biological products: Provided, That in cases of containers or packages prescribed by Ordinance of the Prime Minister, some of the information prescribed in the subparagraphs of Article 56 (1) of the Pharmaceutical Affairs Act and the information prescribed in the following subparagraphs may be omitted, as prescribed by Ordinance of the Prime Minister: | 1. | Texts with which a donor can be identified, in cases the product contains human cells, etc.: Provided, That such texts may be omitted where the donor can be identified by the manufacturing number; |
| 2. | The indication "product subject to long-term follow-up", if such product is designated as subject to long-term follow-up under Article 30 (1); |
| 3. | The indication "advanced biological products for self-treatment", if the donor of human cells, etc. and the recipient thereof are the same person; |
| 4. | Other information prescribed by Ordinance of the Prime Minister. |
| Article 32 (Establishment and Designation of Regulatory Science Center for Advanced Biological Products) |
| (1) | The Minister of Food and Drug Safety may establish a regulatory science center for advanced biological products (hereinafter referred to as the "regulatory science center") or designate a relevant specialized institution, organization, or corporation as a regulatory science center, for the purpose of conducting long-term follow-up on advanced biological products and providing under Article 30 comprehensive information and technology support on advanced biological products. |
| (2) | Where a regulatory science center is established under paragraph (1), it shall be a corporation, and the provisions of the Civil Act governing incorporated foundations shall apply mutatis mutandis to a regulatory science center, except as provided in this Act. |
| (3) | A regulatory science center shall implement the following programs: |
| 1. | Establishment and operation of computer networks necessary for registering and managing details of the administration, sales, and supply of advanced biological products under Article 30 (4) and (5); |
| 2. | Collection and analysis of information on international standards, systems, and trends in domestic and overseas development related to advanced biological products; |
| 3. | Education and publicity of relevant information, such as permission by item, manufacture, and quality control of advanced biological products; |
| 4. | Research on systems and standard specifications for the advancement of regulation on advanced biological products; |
| 5. | Training experts in the manufacturing and quality control of advanced biological products; |
| 6. | Affairs prescribed by Presidential Decree as necessary for the safety control of advanced biological products. |
| (4) | The Minister of Food and Drug Safety may make contributions or provide subsidies to cover expenses necessary for the establishment and operation of a regulatory science center, within the budget. |
| (5) | Matters necessary for the operation, etc. of a regulatory science center, except as provided in this Act, shall be prescribed by the Presidential Decree. |
| Article 33 (Requests to Furnish Data) |
| (1) | Where deemed necessary to perform its duties, such as the collection of adverse events in patients administered with advanced biological products subject to long-term follow-up, a regulatory science center may request the following institutions or persons to furnish relevant data. In such cases, an institution or a person in receipt of the request to submit data shall comply therewith, in the absence of good cause: |
| 1. | The State or a local government; |
| 2. | Public institutions or public organizations; |
| 4. | A pharmacy founder or a medical institution founder; |
| 5. | Persons who may handle advanced biological products including human cell management business entities, manufacturers of advanced biological products, persons who have obtained permission by item, and importers and permitted distributors under Article 45 of the Pharmaceutical Affairs Act. |
| (2) | Article 22 (2) and (3) shall apply mutatis mutandis to requests to furnish data under paragraph (1) and the consolidation of data furnished. In such cases, the "Minister of Health and Welfare" shall be construed as the "Minister of Food and Drug Safety." |
| (3) | Upon receipt of a request from the Minister of Health and Welfare, the head of a regulatory science center shall provide the data furnished under paragraph (1). |
| (4) | Data provided in accordance with paragraphs (1) and (2) shall not be used for purposes other than originally intended. |
| Article 34 (Guidance and Supervision over Regulatory Science Center) |
| (1) | Where necessary for the supervision over a regulatory science center, the Minister of Food and Drug Safety may require the center to file a report or to submit data on its affairs, or issue other necessary orders, and require public officials under his or her control to have access to its office to inspect books, documents, etc. |
| (2) | A public official who enters a relevant place and conducts an inspection under paragraph (1) shall carry identification indicating his or her authority and present it to relevant persons. |
| (3) | The Minister of Food and Drug Safety may periodically check whether the head of a regulatory science center complies with Articles 22 (3) and 33 (4) which apply mutatis mutandis pursuant to Article 33 (2), and may take necessary measures, such as revocation of designation, in cases of a violation of such provisions. |
| (4) | Other matters necessary for the guidance and supervision over a regulatory science center shall be prescribed by Presidential Decree. |
| Article 35 (Classification of Items to Which Advanced Biotechnology Is Applied) |
| (1) | A person who develops a product by making use of genetic materials, cells, or tissues, may apply for the classification of items to the Minister of Food and Drug Safety with respect to whether the relevant product is an advanced biological product. |
| (2) | Upon receipt of an application under paragraph (1), the Minister of Food and Drug Safety shall notify the applicant of the result of review on the classification of items within the period prescribed by Ordinance of the Prime Minister: Provided, That under unavoidable circumstances such as the impracticality of classifying items, the Minister may notify the applicant of an extension of the period and a plan for review of the classification of items. |
| (3) | The Minister of Food and Drug Safety may, if necessary for the review of the classification of items, seek advice from the review committee or consult with the heads of relevant central administrative agencies. |
| (4) | The criteria and contents of the classification of items, the methods of and procedure for applying for the classification of items and notifying the results of review, and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 36 (Designation of Products Subject to Fast-Track Processing) |
| (1) | A person who develops advanced biological products may file an application with the Minister of Food and Drug Safety to designate advanced biological products under development as subject to fast-track processing for permission and review. |
| (2) | Where an advanced biological product subject to the application for fast-track processing falls under any of the following, the Minister of Food and Drug Safety may designate it as a product subject to fast-track processing: |
| 1. | Where the product is to treat a serious illness, such as cancer that has no alternative remedy and threatens life; |
| 3. | Where the product is for the purposes of prevention and treatment in case of a pandemic of infectious diseases spread through bioterrorism and other infectious diseases prescribed in the Infectious Disease Control and Prevention Act. |
| (3) | The Minister of Food and Drug Safety shall notify an applicant of whether designation is granted within 60 days from the date of receipt of the application for designation under paragraph (1). |
| (4) | Details of the standards, procedures, methods, and others for designating products subject to fast-track processing shall be prescribed by Ordinance of the Prime Minister. |
| Article 37 (Fast-Track Processing) |
| (1) | The Minister of Food and Drug Safety shall handle the advanced biological products designated as subject to fast-track processing under Article 36 (2) as follows: |
| 1. | Where a developer divides and submits data necessary for permission by development phase before applying for permission by item and requests preliminary reviews thereof, the Minister shall review the data according to the review plan consulted (hereinafter referred to as “tailored review”); |
| 2. | Where a developer applies for permission by item, the Minister shall review such application in preference to applications for permission by item for drugs that are not designated as subject to fast-track processing; |
| 3. | Where a developer applies for permission by item based on the following data, permission by item shall be granted on condition of managing the safety of the product after it has been released on the market (hereinafter referred to as "conditional permission"): |
| (a) | Clinical trial data showing that the relevant item has efficacy on clinical endpoints prescribed by Ordinance of the Prime Minister; |
| (b) | Clinical trial data showing that the item has efficacy on surrogate endpoints with reasonably predictable clinical benefits in terms of pharmacoepidemiology, pharmacotherapy, pathophysiology, and the like. |
| (2) | Where the Minister of Food and Drug Safety conducts a tailored review, he or she shall consult with the applicant on the type and scope of data to be submitted, submission schedules, and timing of notifying the results of the review, etc.; examine data submitted in accordance with the review plan consulted; and notify the applicant of the results of such review. |
| (3) | Where the Minister of Food and Drug Safety grants conditional permission, he or she may attach the following conditions: |
| 1. | Where there is an unclear correlation between the efficacy of the relevant advanced biological product and the items of paragraph (1) 3, the applicant shall conduct a clinical trial for reinforcement; |
| 2. | The applicant shall submit data, etc. on clinical trials for persons administered with the product within a period separately prescribed, in order to secure safety and efficacy in the human body; |
| 3. | Only medical personnel who have received training or experience necessary to handle the relevant advanced biological product may prescribe the advanced biological product; |
| 4. | The applicant shall perform specific medical procedures for a patient, such as frequent monitoring of vital signs. |
| (4) | Matters necessary for, among other things, the methods of application, processing procedures, and conditional permission, etc. for tailored review under paragraphs (1) through (3) shall be prescribed by Ordinance of the Prime Minister. |
| Article 38 (Revocation of Designation of Products Subject to Fast-Track Processing) |
The Minister of Food and Drug Safety shall revoke the designation of a product subject to fast-track processing or permission by item granted under Article 23 (2) and (3) and Article 27 (1) where an advanced biological product designated as a product subject to fast-track processing under Article 36 (2) falls under any of the following subparagraphs: | 1. | Where a person has obtained designation by fraud or other improper means; |
| 2. | Where a person who has obtained conditional permission fails to comply with the conditions; |
| 3. | Where a person ceases to fall under any subparagraph of Article 36 (2) prior to obtaining permission by item. |
| Article 39 (Reporting and Inspections) |
| (1) | The Minister of Health and Welfare may instruct as follows: |
| 1. | The head and employees of a regenerative medical institution shall be required to file a report and submit documents as necessary to perform the duties in relation to clinical research of advanced regenerative medicine; |
| 2. | The Minister may require relevant public officials to enter a place of a regenerative medical institution to inspect its facilities and documents or to question relevant persons. |
| (2) | The Minister of Food and Drug Safety may instruct as follows: |
| 1. | A manufacturer of advanced biological products, a person who has obtained permission by item for advanced biological products, an importer thereof, or a person who has obtained approval for a clinical trial protocol, the head of a cell processing establishment, a human cell management business entity, and other persons engaged in the business of handling advanced biological products shall be required to submit necessary documents or other data; |
| 2. | Relevant officials shall enter a factory, warehouse, store, or office where advanced biological products are manufactured, stored or handled; a place where advanced biological products for clinical trials are handled; a place where human cells, etc. are handled; and other places where a business of handling advanced biological products, and inspect facilities, relevant books, documents, or other articles or question relevant persons; |
| 3. | Where an advanced biological product is suspected of violating Article 60 of the Pharmaceutical Affairs Act or has defects or where its ingredients or materials or human cells, etc. are likely to have problems, a minimum quantity of the goods necessary for quality inspections, etc. shall be collected. |
| (3) | A person who has access, conducts an inspection, questions relevant persons, or collects goods under paragraph (1) or (2) shall carry identification indicating his or her authority and a document showing the period and scope of investigation, the person in charge of investigation, relevant statutes and regulations, and other matters prescribed by Ordinance of the Ministry of Health and Welfare and present them to relevant persons. |
| (4) | The authorities and scope of duties of relevant public officials prescribed in paragraph (3) and other necessary matters shall be prescribed by Presidential Decree. |
| Article 40 (Order for Recall and Destruction) |
| (1) | The Minister of Health and Welfare may issue an order for a regenerative medical institution that have used human cells, etc. which have caused or are likely to pose a risk to public health (hereinafter referred to as “harmful human cells, etc.”) for clinical research of advanced regenerative medicine to take necessary measures, such as suspending the use of the human cells, etc.; and where it is recognized that harmful human cells, etc. have caused or are likely to cause harm to public health, the Minister may order a regenerative medical institution to recall and destroy harmful human cells, etc. under its management or to take other necessary measures. |
| (2) | The Minister of Food and Drug Safety may order the head of a cell processing establishment or a human cell management business entity, who keeps, processes or supplies harmful human cells, etc., to take necessary measures such as suspending the use of such harmful human cells, etc.; and if the Minister deems that any harmful human cell, etc. causes or is likely to cause a harm to public health, he or she may order the head of a cell processing establishment or a human cell management business entity to recall or destroy harmful human cells, etc. under its management or to take other necessary measures. |
| (3) | Where a person in receipt of an order under paragraph (1) or (2) fails to comply with the order or urgent needs arise for public health, the Minster of Health and Safety and the Minister of Food and Drug Safety may have relevant public officials destroy relevant human cells, etc. or impose necessary dispositions. |
| (4) | Matters necessary for recall, destruction, and other measures for a regenerative medical institution, among those related to recall and destruction under paragraphs (1) through (3), shall be prescribed by Ordinance of the Ministry of Health and Welfare, and matters necessary for recall, destruction, and other measures for a head of a cell processing establishment and a human cell management entity shall be prescribed by Ordinance of the Prime Minister. |
| Article 41 (Corrective Orders) |
The Minister of Health and Welfare or the Minister of Food and Drug Safety may order any of the following persons to correct a violation within a specified period of time:
| 1. | A regenerative medical institution that uses human cells provided by a person other than a cell processing establishment for clinical research of advanced regenerative medicine in violation of the main clause of Article 10 (3) or that fails to comply with the standards for processing human cells, etc. prescribed by Ordinance of the Ministry of Health and Welfare in violation of the proviso of the same paragraph; |
| 2. | A regenerative medical institution which fails to record, manage, and keep matters related to clinical research of advanced regenerative medicine, or fails to report such records, in violation of Article 10 (4); |
| 3. | The head of a cell processing establishment who fails to record and keep matters related to the cell processing business or fails to report such records, in violation of Article 15 (4); |
| 4. | A human cell management business entity that fails to prepare and keep records of the business of managing human cells, etc., in violation of Article 29 (2). |
| Article 42 (Revocation of Permission and Suspension of Business) |
| (1) | Where a regenerative medical institution falls under any of the following subparagraphs, the Minister of Health and Welfare may revoke the designation thereof or order to fully or partially suspend its business for a period of up to one year: Provided, That he or she shall revoke such designation in cases falling under subparagraph 1: |
| 1. | Where it obtains the designation under Article 10 (1) by fraud or other improper means; |
| 2. | Where it ceases to meet the standards for designation under Article 10 (2); |
| 3. | Where it fails to comply with the standards for conducting clinical research of advanced regenerative medicine, in violation of Article 10 (4); |
| 4. | Where it charges expenses incurred in conducting clinical research of advanced regenerative medicine to a human subject, in violation of Article 10 (5); |
| 5. | Where it fails to undergo deliberation under Article 12 (1) or to obtain approval under Article 12 (3), or conducts clinical research of advanced regenerative medicine in a manner different from that deliberated and approved; |
| 6. | Where it fails to report an adverse reaction to the head of a safety management institution, in violation of Article 20 (2); |
| 7. | Where it fails to comply with any order or disposition issued under Article 39, 40, or 41; |
| 8. | Where it refuses, obstructs, or evades access, investigation, or inspection by a relevant public official provided in Article 39 (1); |
| 9. | Where it violates this Act or any orders issued under this Act. |
| (2) | Where a manufacturer or importer of advanced biological products, person who has obtained permission by item, human cell management entity, or cell processing establishment falls under any of the following subparagraphs, the Minister of Food and Drug Safety may revoke such permission or acceptance of a report, or may order closure of a contract manufacturing business office or business place (limited to cases reported pursuant to Article 27 (1); hereafter the same shall apply in Article 43), prohibition on manufacturing of items or on importation of items, or suspension of the whole or part of the business under this Act for a period of up to one year: Provided, That he or she shall revoke such permission in cases falling under subparagraph 1. |
| 1. | Where he, she, or it obtains permission under Article 15 (1) or 28 (1) by fraud or other improper means; |
| 2. | Where he, she, or it ceases to meet the establishment standards provided in Article 15 (1), 23 (1), 27 (3) or 28 (1); |
| 3. | Where he, she, or it fails to obtain permission by item or permission for modification, in violation of Article 23 (2), (3), or (7) or Article 27 (1); |
| 4. | Where he, she, or it falls under any of the subparagraphs 1 through 5 of Article 23 (6) (limited to an importer in cases falling under subparagraph 5): Provided, That the same shall not apply where the representative of a corporation falls under any of such provisions and is replaced within six months; |
| 5. | Where he, she, or it falls under Article 23 (6) 6 and 7 or Article 27 (4) 2: Provided, That the same shall not apply where the representative of a corporation falls under any of such provisions and is replaced within six months; |
| 6. | Where he, she, or it manufactures advanced biological products, in violation of Article 26 (1); |
| 7. | Where he, she, or it fails to files a registration or a registration of modification or fails to file a report on modification under Article 27 (7) and (8), or files a registration, a registration on modification, or a notificationof modification by fraud or other improper means; |
| 8. | Where he, she, or it manages human cells, etc., in violation of Article 29; |
| 9. | Where he, she, or it fails to report a serious adverse event, in violation of Article 30 (3); |
| 10. | Where he, she, or it states information, in violation of Article 31; |
| 11. | Where he, she, or it fails to comply with any order or disposition issued under Article 39, 40, or 41; |
| 12. | Where he, she, or it refuses, interferes with, or evades the entry, inspection, inquiry, or collection by a relevant public official under Article 39 (2); |
| 13. | Where he, she, or it manufactures, imports, or distributes advanced biological products which caused or are likely to cause any risk to the public health or which are recognized as having no efficacy; |
| 14. | Where he, she, or it violates this Act or any orders issued under this Act. |
| (3) | Detailed standards for administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare, and detailed standards for administrative dispositions under paragraph (2) shall be prescribed by Ordinance of the Prime Minister in consideration of the type, severity, etc. of the relevant violations. |
Where the Minister of Health and Welfare or the Minister of Food and Drug Safety intends to revoke permission, designation, or acceptance of a report, close a contract manufacturing business office or business place, prohibit the manufacturing or importation of items under Article 42, he or she shall hold a hearing.
| Article 44 (Transfer of Data upon Closure of Business) |
Where a regenerative medical institution, a cell processing establishment, a human cell management entity, a person who has obtained approval for a clinical trial protocol, a person who has obtained permission by item, or an importer closes or suspends business or where a permission, etc. is revoked for him, her, or it under Article 42, he, she, or it shall process human cells, etc. or data, etc. related to long-term follow-up as prescribed by Presidential Decree or transfer them to other establishments or institutions.
| Article 45 (Penalty Surcharges Imposed in Lieu of Disposition to Suspend Business) |
| (1) | Where the Minister of Health and Welfare or the Minister of Food and Drug Safety shall order the suspension of business pursuant to Article 42 and the suspension of business is likely to cause serious inconvenience to users involved or to undermine public interest, he or she may impose a penalty surcharge of up to 200 million won (or 100 million won in cases of a cell processing establishment or human cell management business entity) in lieu of the suspension of business. |
| (2) | Matters necessary for the amount, etc. of penalty surcharges corresponding to the kind, severity, etc. of violations subject to imposition of penalty surcharge under paragraph (1) shall be prescribed by Presidential Decree. |
| (3) | Where necessary for imposing a penalty surcharge, the Minister of Health and Welfare and the Minister of Food and Drug Safety may request the head of a competent tax office to provide taxation information with a document stating the following: |
| 1. | Personal information on a taxpayer; |
| 2. | Purpose of the use of information; |
| 3. | Data on sales, forming the basis for imposing penalty surcharges. |
| (4) | If a person on whom a penalty surcharge has been imposed pursuant to paragraph (1) fails to pay it by the payment deadline, the Minister of Health and Welfare or the Minister of Food and Drug Safety shall revoke the imposition of the penalty surcharge under paragraph (1) and then suspend the business under Article 42 or collect the penalty surcharge in the same manner as delinquent national taxes are collected, as prescribed by Presidential Decree: Provided, That where it is impossible to suspend business due to business closure, etc., the penalty surcharge shall be collected in the same manner as delinquent national taxes. |
| (5) | In order to collect a penalty surcharge in arrears pursuant to paragraph (4), the Minister of Health and Welfare or the Minister of Food and Drug Safety may request the submission of any of the following data from the relevant person prescribed in the following. In such cases, a person upon receipt of such request shall comply with it, unless there is a compelling reason not to do so: |
| 3. | A certified copy of the motor vehicle register referred to in Article 7 of the Motor Vehicle Management Act: The Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, or a Special Self-Governing Province Governor (hereinafter referred to as "Mayor/Do Governor"). |
| (6) | Penalty surcharges collected pursuant to paragraphs (1) and (4) shall vest in the State. |
| (1) | Where a person intends to perform the following activities in connection with the affairs under the jurisdiction of the Ministry of Food and Drug Safety, he or she shall pay a fee as prescribed by Ordinance of the Prime Minister. The same shall also apply to permission, renewal, notification, or registration, or the modification of the matters prescribed by Ordinance of the Prime Minister: |
| 1. | A person who intends to apply for permission, renewal, notification, registration, or designation; |
| 2. | A person who intends to apply for classification of items pursuant to Article 35; |
| 3. | Requesting other matters prescribed by Ordinance of the Prime Minister. |
| (2) | Notwithstanding paragraph (1), where an applicant for permission by item of an advanced biological product designated as subject to fast-track processing pursuant to Article 36 (2) is a small or medium entrepreneur under Article 2 of the Framework Act on Small and Medium Enterprises, the fee for permission by item may be reduced or exempted, as prescribed by Ordinance of the Prime Minister. |
CHAPTER Ⅵ SUPPLEMENTARY PROVISIONS
| Article 47 (Delegation and Entrustment of Authority) |
| (1) | The Minister of Health and Welfare may delegate part of his or her authority under this Act to the head of a safety management institution or Mayor/Do Governor, as prescribed by Presidential Decree. <Amended on Aug. 11, 2020> |
| (2) | The Minister of Food and Drug Safety may delegate part of his or her authority bestowed by this Act to the head of a local food and drug safety office or the Director General of the National Institute of Food and Drug Safety Evaluation, as prescribed by Presidential Decree. |
| (3) | The Minister of Health and Welfare may entrust the head of a relevant central administrative agency or a support institution with some of the affairs regarding support, etc. of clinical research of advanced biological products under this Act, as prescribed by Presidential Decree. |
| (4) | The Minister of Food and Drug Safety may partially entrust his or her duties regarding the management of advanced biological products prescribed in this Act to a regulatory science center as prescribed by Presidential Decree. |
| Article 48 (Prohibition on False or Exaggerated Advertisement) |
| (1) | No person shall place any false or exaggerated advertisement including medically unrecognized contents about the efficacy of clinical research of advanced regenerative medicine, procedures for and methods of storing human cells, etc. and the quality thereof. |
| (2) | Matters necessary for the contents, scope, etc. of a false or exaggerated advertisement provided in paragraph (1) shall be prescribed by Presidential Decree. |
| Article 49 (Prohibition on Purchase and Sale of Human Cells) |
| (1) | No person shall provide or promise to provide his or her human cells, etc. in exchange for money, property benefits, or other compensatory benefits. |
| (2) | No person shall be provided with or promise to be provided with human cells, etc. of any third person in exchange for money, property benefits, or other compensatory benefits. |
| (3) | No person shall instigate, assist, or mediate any act violating paragraph (1) or (2). |
| (4) | When a person becomes aware that any act violating paragraph (1) or (2) has been done, he or she shall not recover or use human cells, etc. related to such act. |
| Article 50 (Prohibition on Disclosure of Confidential Information) |
Except as provided in this Act or other statutes, a manufacturer of advanced biological products, a person who has obtained permission by item for advanced biological products, an importer thereof, or a person who has obtained approval for a clinical trial protocol, or a person who is or has been employed in a safety management institution, regenerative medical institution, cell processing establishment, policy committee, review committee, subcommittee, support institution, or regulatory science center shall neither divulge any information on any other person which has come to his or her knowledge in the course of performing his or her duties nor use such information for any improper purpose.
| Article 51 (Prohibition on Use of Similar Name) |
No person, other than a manufacturer of advanced biological products, a person who has filed a notification of contract manufacturing and distribution business, a person who has obtained permission by item, an importer, a human cell management entity, or a person who is not designated as a cell processing establishment, shall use the name “advanced regenerative medicine implementation institution” or any similar name.
| Article 52 (Legal Fiction as Public Officials for Purposes of Applying Penalty Provisions) |
| 1. | A member of the policy committee; |
| 2. | An executive or employee of a support institution; |
| 3. | A member of the review committee or a subcommittee referred to in Articles 13 (4); |
| 4. | An executive or employee of a regulatory science center. |
| Article 53 (Special Cases concerning Advanced Biological Products for Animals) |
Among matters under the jurisdiction of the Minister of Food and Drug Safety under this Act, advanced biological products to be exclusively used for animals shall fall under the jurisdiction of the Minister of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries; and the "Minister of Food and Drug Safety" in the relevant provisions of this Act shall be construed as "Minister of Agriculture, Food and Rural Affairs" or “Minister of Oceans and Fisheries,” and "Ordinance of the Prime Minister” as "Ordinance of the Ministry of Agriculture, Food and Rural Affairs" or "Ordinance of the Ministry of Oceans and Fisheries." In such cases, when the Minister of Agriculture, Food and Rural Affairs intends to formulate Ordinance of the Ministry of Agriculture, Food and Rural Affairs or the Minister of Oceans and Fisheries intends to formulate Ordinance of the Ministry of Oceans and Fisheries, he or she shall consult in advance with the Minister of Food and Drug Safety.
| Article 54 (Succession to Status of Manufacturers) |
| (1) | Where a manufacturer or importer of advanced biological products, or a person who has obtained permission by item of advanced biological products, a person who has filed a notification of contract manufacturing and distribution business, a human cell management business entity, or the head of a cell processing establishment (hereafter referred to as "manufacturer, etc." in this Article and Article 55) is deceased or transfers his, her, or its business or where there is a merger or consolidation of a manufacturer, etc. who is a corporation, the heir, transferee, or a surviving or resulting corporation following merger or consolidation shall succeed to the status of the manufacturer, etc.: Provided, That the same shall not apply where a transferee of a business or a surviving or resulting corporation following merger or consolidation falls under any of the following cases: |
| 1. | A manufacturer of advanced biological products, a person who has obtained permission by item, or a person who has filed a notification of contract manufacturing and distribution business: Where he or she falls under any of the subparagraphs of Article 23 (6); |
| 2. | A human cell management business entity or the head of a cell processing establishment: Where a person for whom one year has not passed after his or her permission was revoked pursuant to Article 42. |
| (2) | Where a manufacturer of advanced biological products, a person who has obtained permission by item, a person who has filed a notification of contract manufacturing and distribution business, or an importer has transferred his or her business involving advanced biological products for which permission has been obtained or a notification has been filed regarding manufactured items or imported items pursuant to Article 23 (2) and (3) or 27 (1), the manufacturer of advanced biological products, person who has obtained permission by item, person who has filed a notification of contract manufacturing and distribution business, or importer, who takes over such business, shall succeed to the status of the transferring manufacturer, person who obtained permission by item, person who filed a notification of contract manufacturing and distribution business, or importer with respect to permission for the relevant items. |
| Article 55 (Succession to Administrative Sanctions) |
Where the status has been succeeded pursuant to Article 54, a transferee, a corporation surviving a merger, or a corporation incorporated by a merger shall succeed to the effects of administrative dispositions on the previous manufacturer, etc. and importer for one year from the date such disposition took place, and where the procedures for administrative dispositions are underway, the procedures for disposition of administrative sanctions may proceed for the transferee, the corporation surviving a merger, the corporation incorporated by a merger: Provided, That the same shall not apply where a new manufacturer, etc. (excluding the succession to the status by inheritance) or an importer succeeds to business and is not aware of such disposition or violation.
| Article 56 (Establishment of Organizations) |
Manufacturers of advanced biological products, persons who have obtained permission by item, and importers thereof may establish an incorporated association, respectively, in order to ensure their autonomous activities and common interests and to contribute to improving the public health.
CHAPTER VII PENALTY PROVISIONS
| Article 57 (Penalty Provisions) |
| (1) | Any person who falls under any of the following subparagraphs shall be punished by imprisonment with labor for not more than five years or by a fine not exceeding 50 million won: |
| 1. | A person who conducts clinical research of advanced regenerative medicine, without being designated as a regenerative medical institution, in violation of Article 10 (1); |
| 2. | A person who conducts clinical research of advanced regenerative medicine without obtaining a written consent from human subjects or their parents or representatives, in violation of Article 11 (1) or (2); |
| 3. | A person who conducts clinical research of advanced regenerative medicine without undergoing deliberation under Article 12 (1) or obtaining approval under Article 12 (3) or in a manner different from that deliberated and approved; |
| 4. | A person who engages in the business of processing cells without obtaining permission for a cell processing establishment, in violation of Article 15 (1); |
| 5. | A person who extracts human cells, etc. without a written consent of a person subject to recovery or his or her parent or representative in violation of Article 16 (3) or (4) (including cases applied mutatis mutandis pursuant to Article 28 (5)); |
| 6. | A person who entrusts his or her duties to an institution other than that prescribed by Presidential Decree, in violation of Article 17 (2) (including cases applied mutatis mutandis pursuant to Article 28 (5)); |
| 7. | A person who fails to comply with the matters to be observed referred to in Article 18 or 29; |
| 8. | A person who fails to obtain permission, to file a notification, to obtain permission for modification, or to file a notification of modification, in violation of Article 23 (1) through (3) or (7); |
| 9. | A person who manufacturers advanced biological products, in violation of Article 26 (1) 1 or 2; |
| 10. | A person who fails to obtain permission, to file a notification, to obtain permission for modification, or to file a notification of modification, in violation of Article 27 (1); |
| 11. | A person who engages in the business of managing human cells, etc. without obtaining permission for a human cell management business entity, in violation of Article 28 (1); |
| 12. | A person who gives, receives, or promises to give or receive human cells, etc., or solicits, aids, or arranges such act, in violation of Article 49 (1) through (3). |
| (2) | Imprisonment with labor and fines prescribed in paragraph (1) may be imposed concurrently. |
| Article 58 (Penalty Provisions) |
| (1) | Any of the following persons shall be punished by imprisonment with labor for not more than three years or by a fine not exceeding 30 million won: |
| 1. | A person who conducts clinical research of advanced regenerative medicine using human cells, etc. other than those supplied by a cell processing establishment, in violation of the main clause of Article 10 (3); |
| 2. | A person who obstructs the duties of a manufacturing manager, in violation of Article 25 (3) (including cases applied mutatis mutandis pursuant to Article 27 (5)); |
| 3. | A person who fails to comply with an order requiring recall, destruction, etc. under Article 40 (1) or (2), or who refuses, obstructs, or evades a disposition such as destruction under paragraph (3) of the same Article; |
| 4. | A person who recovers or uses human cells, in violation of Article 49 (4); |
| 5. | A person who divulges information or uses it for improper purposes, in violation of Article 50. |
| (2) | Imprisonment with labor and fines prescribed in paragraph (1) may be imposed concurrently. |
| Article 59 (Penalty Provisions) |
| (1) | Any person who falls under any of the following subparagraphs shall be punished by imprisonment with labor for not more than one year or by a fine not exceeding 10 million won: |
| 1. | A person who obtains the designation of a regenerative medical institution under Article 10 (1) by fraud or other improper means; |
| 2. | A person who has obtained permission for a cell processing establishment under Article 15 (1) by fraud or other improper means; |
| 3. | A person who fails to manage manufacturing, in violation of Article 24 (including cases applied mutatis mutandis pursuant to Article 25 (5)) or Article 25 (2) (including cases applied mutatis mutandis pursuant to Article 27 (5)); |
| 4. | A person who fails to comply with the duty to manage manufacturing or production, in violation of Article 25 (1) (including cases applied mutatis mutandis pursuant to Article 27 (5)) or Article 26 (1) 3 through 5 (including cases applied mutatis mutandis pursuant to Article 27 (5)); |
| 5. | A person who obtains permission for a human cell management business under Article 28 (1) by fraud or other improper means; |
| 6. | A person designated as subject to fast-track processing under Article 36 by fraud or other improper means; |
| 7. | A person who places a false or exaggerated advertisement, in violation of Article 48. |
| (2) | Imprisonment with labor and fines prescribed in paragraph (1) may be imposed concurrently. |
| (3) | Where a person is sentenced to punishment for committing a crime prescribed in paragraph (1) 4 and commits a crime prescribed in that subparagraph again within three years from the date his or her sentence becomes final and conclusive, the punishment shall be aggravated by up to 1/2 of the corresponding punishment. |
| Article 60 (Penalty Provisions) |
Any of the following persons shall be subject to an administrative fine not exceeding two million won:
| 1. | When he or she has fails to make labeling statements as required, in violation of Article 31; |
| 2. | A person who violates an order requiring reporting under Article 39 (1) or (2) or who refuses, obstructs, or evades an investigation, inspection, enquiry, or collection by a relevant public official. |
| Article 61 (Concurrent Imposition of Suspension of Qualification) |
Where any person is punished by imprisonment with labor for a limited term under Articles 57 (1) 1 through 4 and 58 (1) 1, suspension of qualifications for not more than 10 years may be concurrently imposed.
| Article 62 (Joint Penalty Provisions) |
Where a representative of a corporation, or an a representative or employee of, or any other person employed by, a corporation or an individual commits a violation falling under Articles 57 through 60 in connection with the business of the corporation or the individual, not only shall such violator be punished, but the corporation or the individual shall also be punished by a fine under the relevant provisions: Provided, That the same shall not apply where the corporation or the individual has not been negligent in paying due attention and supervision concerning the relevant business in order to prevent such violation.
| Article 63 (Administrative Fines) |
| (1) | A person falling under any of the following subparagraphs shall be subject to an administrative fine not exceeding 10 million won: |
| 1. | A person who fails to record, manage, and keep the records of clinical research of advanced biological products, fails to report such records, or fails to comply with the standards for conducting clinical research of advanced biological products, in violation of Article 10 (4); |
| 2. | A person who charges expenses related to clinical research of advanced biological products to a human subject, in violation of Article 10 (5); |
| 3. | A person who fails to explain matters regarding consent, in violation of Article 11 (3); |
| 4. | A person who fails to record, keep or report matters regarding cell processing business, in violation of Article 15 (4); |
| 5. | A person who fails to report the occurrence of adverse reactions to the head of a safety management institution, in violation of Article 20 (2); |
| 6. | A person who fails to follow instructions regarding the performance of long-term follow-up, in violation of Article 21 (2); |
| 7. | A person who fails to register the details of administering, selling, or supplying advanced biological products, in violation of Article 30 (4) or (5); |
| (2) | Any person who fails to transfer data, in violation of Article 44, shall be subject to an administrative fine not exceeding three million won. |
| (3) | Any of the following persons shall be subject to an administrative fine not exceeding one million won: |
| 1. | A person who fails to report closure of business, etc., in violation of Article 10 (6), 15 (5), or 28 (3); |
| 2. | A person who fails to renew a permit or a certificate of notification, in violation of Article 15 (6), 23 (8) (including cases applied mutatis mutandis pursuant to Article 27 (5)), or Article 28 (4); |
| 3. | A person who fails to report the performance of production and export, in violation of Article 26 (2) (including cases applied mutatis mutandis pursuant to Article 27 (5)); |
| 4. | A person who uses a similar name, in violation of Article 51. |
| (4) | Administrative fines prescribed in paragraphs (1) through (3) shall be imposed and collected by the Minister of Health and Welfare or the Minister of Food and Drug Safety, as prescribed by Presidential Decree. |
ADDENDA <Act No. 16556, Aug. 27, 2019>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Article 2 (Transitional Measure concerning Permission and Reporting)
| (1) | A person who manufactures (including contract manufacturing) or imports advanced biological products, after obtaining permission for manufacturing business or filing a notification of import business or a contract manufacturing and distribution business with regard to drugs under the Pharmaceutical Affairs Act as at the time this Act enters into force, shall be deemed to have obtained permission or to have filed a notification under Article 23 (1) or (3) or 27 (1): Provided, That he or she shall again obtain permission from or file a notification with the Minister of Food and Drug Safety within one year after this Act enters into force. |
| (2) | A person who has obtained permission by item or permission for imported items with regard to advanced biological products under the Pharmaceutical Affairs Act as at the time this Act enters into force shall be deemed to have obtained permission by item pursuant to Article 23 (2) and (3) or 27 (1): Provided, That he or she shall again obtain permission from the Minister of Food and Drug Safety within one year after this Act enters into force. |
Article 3 (Transitional Measures concerning Labeling on Containers)
Article 4 (Transitional Measures concerning Permission for Cell Processing Establishments and Human Cell Management Entities)
A person who is engaged in a cell processing business or business of managing human cells, etc. as at the time this Act enters into force shall be deemed to have obtained permission prescribed in Article 15 or 28: Provided, That such person shall obtain permission under Article 15 or 28 within six months after this Act enters into force. Article 5 (Transitional Measures concerning Disposition)
Public notice, dispositions, and other acts issued or taken by administrative agencies or applications, notifications, or other acts filed with or taken toward administrative agencies under the Pharmaceutical Affairs Act with regard to advanced biological products before this Act enters into force shall be deemed acts taken by or toward administrative agencies under this Act. Article 6 (Transitional Measures concerning Administrative Dispositions and Penalty Surcharges)
Article 7 Omitted.
Article 8 (Relationship to Other Statutes or Regulations)
Where the Pharmaceutical Affairs Act or any provision thereof is cited by other statutes or regulations as at the time this Act enters into force, and if provisions corresponding thereto exist herein, this Act or the relevant provisions thereof shall be deemed cited as well.
ADDENDA <Act No. 17472, Aug. 11, 2020>
Article 1 (Enforcement Date)
This Act shall enter into one month after the date of its promulgation: Provided, That ... the amended provisions of any Act, which is amended pursuant to Article 4 of the Addenda and promulgated before this Act enters into force but the enforcement date of which has yet to arrive, shall enter into force on the enforcement date of such Act. Articles 2 through 5 Omitted.