"Products prescribed by Presidential Decree" in subparagraph 2 of Article 2 of the Act on Cord Blood Management and Research (hereinafter referred to as the "Act") means nucleated cells and plasma extracted through minimal manipulation such as the separation, washing, freezing, thawing, etc. of the ingredients of human cord blood (hereinafter referred to as "cord blood").
| Article 3 (Composition of Cord Blood Committee) |
| (1) | The term of office of members of the Cord Blood Committee established under Article 6 of the Act (hereinafter referred to as the "Committee") shall be two years. |
| (2) | The chairperson of the Committee (hereinafter referred to as the "chairperson") and the vice chairperson thereof shall be elected from among Committee members. |
| (3) | The chairperson shall represent the Committee and have general supervision and control of its business affairs. |
| (4) | The vice chairperson shall assist the chairperson and shall act on behalf of the chairperson if the chairperson is unable to perform his or her duties due to an unavoidable circumstance. |
| Article 3-2 (Dismissal of Committee Members and Termination of Commission) |
Where a Committee member under the subparagraphs of Article 6 (3) of the Act falls under any of the following, the Minister of Health and Welfare may dismiss such member or terminate his or her commission: | 1. | Where he or she is unable to perform his or her duties due to any mental or physical disabilities; |
| 2. | Where he or she engages in misconduct in relation to his or her duties; |
| 3. | Where he or she is deemed unfit to be a Committee member due to neglect of duties, injury to dignity, or other reason; |
| 4. | Where he or she voluntarily expresses that it is impracticable for him or her to perform his or her duties. |
[This Article Newly Inserted on Dec. 31, 2015]
| Article 4 (Operation of Committee) |
| (1) | The chairperson shall convene and preside over Committee meetings. |
| (5) | A meeting of the Committee shall be convened by the chairperson in any of the following cases: |
| 1. | Where the Minister of Health and Welfare requests a convocation; |
| 2. | Where at least 1/3 of the members of the Committee request the convocation of a meeting; |
| 3. | Other cases deemed necessary by the chairperson. |
| (3) | A majority of the members of the Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| (4) | If deemed necessary, the chairperson may request relevant public officials or experts to appear before the Committee to state their opinions. |
| (5) | The Committee shall have an executive secretary to handle its business affairs, who shall be designated by the Minister of Health and Welfare from among public officials affiliated with the Ministry of Health and Welfare. |
| (6) | The chairperson shall report the matters deliberated upon by the Committee to the Minister of Health and Welfare without delay. |
| Article 5 (Specialized Committees) |
| (1) | The Committee may have specialized committees by field to review matters to be deliberated in a specialized manner. |
| (2) | A specialized committee shall be composed of up to 7 expert members including 1 chairperson. |
| (3) | The chairperson of each specialized committee shall be appointed by the chairperson from among the members of the Committee, following a resolution by the Committee. |
| (4) | Expert members of a specialized committee shall be commissioned by the chairperson following a resolution by the Committee from among persons who have extensive knowledge of and experience in cord blood. |
| (5) | The chairperson of a specialized committee shall report the results of review conducted by the specialized committee to the Committee. |
| Article 6 (Payment of Allowances) |
The Minister of Health and Welfare may pay allowances and travel expenses to members, expert members, and relevant experts who attend meetings of the Committee and specialized committees within the budget: Provided, That this shall not apply where a public official attends a meeting in direct connection with his or her business affairs.
| Article 7 (Detailed Operational Regulations) |
Except as provided in this Decree, matters necessary for the operation of the Committee and specialized committees shall be determined by the chairperson following a resolution by the Committee.
| Article 8 (Matters to Be Observed when Collecting Cord Blood) |
| (1) | A person who intends to collect cord blood pursuant to Article 8 of the Act shall observe the following matters: |
| 1. | Manipulations related to collection shall be conducted under aseptic conditions; |
| 3. | When collecting cord blood, at least 5 milliliters of the maternal blood shall be collected separately for testing: Provided, That in cases of cord blood entrusted through cord blood entrustment (hereinafter referred to as "family cord blood"), this shall not apply with the express consent of the cord blood entruster; |
| 4. | After collection, the cord blood shall be sealed to prevent contamination or loss. |
| (2) | A person who collects cord blood pursuant to paragraph (1) shall prepare a cord blood collection record, including the following matters, and retain the record for 5 years: |
| 1. | The name, date of birth, address, and contact information of the mother; |
| 2. | The name of a medical institution defined in Article 3 of the Medical Service Act that has collected the cord blood (hereinafter referred to as "collecting medical institution"); |
| 3. | The name of the doctor in charge; |
| 4. | The apgar score, which indicates the gender, gestational age, birth weight, date and time of birth, form of delivery, and health status at birth of the newborn baby; |
| 5. | The date, time, and method of collecting cord blood, and peculiarities of the collection; |
| 6. | The name and signature of the person who has collected the cord blood. |
| (3) | A collecting medical institution or a cord blood bank shall transport cord blood collected pursuant to paragraph (1) to a cord blood bank by the following means: |
| 1. | The cord blood storage container shall be transported after placing it in another sealed container; |
| 2. | The collected cord blood shall be stored and transported at a temperature of not lower than 4 degrees Celsius but not higher than 25 degrees Celsius; |
| 3. | The cord blood shall be transported in an appropriate container capable of maintaining the storage temperature under subparagraph 2 in consideration of the transport distance and time; |
| 4. | The following matters shall be indicated on the outer packaging: |
| (a) | The name, location, and telephone number of the collecting medical institution; |
| (b) | The name, location, telephone number, and addressee of the cord blood bank; |
| (c) | A cautionary note indicating that exposure to radiation or biological contamination shall not occur; |
| 5. | Transportation records shall be prepared to verify the transportation process from the collecting medical institution to the cord blood bank; |
| 6. | The maternal blood for testing under paragraph (1) 3 and a copy of the cord blood collection record under paragraph (2) shall be transported together. |
| (4) | The consent to the collection of cord blood under Article 8 (3) of the Act shall be in the form of a written consent prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 9 (Cases Where Unqualified Cord Blood or Cord Blood Products Need Not Be Discarded) |
"Purpose prescribed by Presidential Decree, such as medical research and manufacture of medicines" in the proviso of Article 10 (4) of the Act means any of the following purposes: <Amended on March 3, 2020> | 1. | Medical and pharmaceutical research for the diagnosis, prevention, and treatment of diseases; |
| 2. | Basic research on the characteristics or differentiation of stem cells; |
| 5. | Use as a sample for quality control of cord blood, the testing of cord blood, and evaluation of the appropriateness of the control of cord blood (hereinafter referred to as "quality control"). |
| Article 10 (Disqualification Criteria for Cord Blood and Cord Blood Products) |
The disqualification criteria for cord blood and cord blood products, testing methods, and the criteria for determination under Article 10 (6) of the Act shall be as specified in attached Table 1.
| Article 11 (Standards and Procedures for Permission for Cord Blood Banks) |
| (1) | A person who intends to open a cord blood bank pursuant to Article 11 (1) of the Act shall be equipped with the facilities, equipment, human resources, and quality control system specified in attached Table 2, and shall submit to the Minister of Health and Welfare an application for permission (including electronic documents) prescribed by Ordinance of the Ministry of Health and Welfare along with the following documents (including electronic documents): |
| 1. | Documents classified as follows: |
| (a) | Where a person who intends to obtain permission is a general hospital under Article 3 (2) 3 (e) of the Medical Service Act (hereinafter referred to as "general hospital"): 1 copy of a certificate of permission to open a medical institution; |
| (b) | Where a person who intends to obtain permission is an educational foundation that owns a general hospital: 1 copy of the incorporation permit and 1 copy of the articles of incorporation; |
| (c) | Where the person who intends to obtain permission is a corporation whose main purpose of establishment is business related to cord blood: 1 copy each of the certificate of incorporation or business registration, the articles of incorporation, and the business plan; |
| 2. | The medical license of the medical director under Article 19 (1) of the Act (hereinafter referred to as "medical director"): 1 copy; |
| 3. | The floor plan and structural description of the building to be used as a cord blood bank: 1 copy each; |
| 4. | A document stating the current status of facilities, equipment, and human resources: 1 copy; |
| 5. | The quality management system established pursuant to subparagraph 4 of attached Table 2: 1 copy; |
| 6. | Guidelines on the business affairs of managing cord blood prepared pursuant to subparagraph 4 (d) of attached Table 2: 1 copy. |
| (2) | The Minister of Health and Welfare, who has received an application under paragraph (1), shall verify the corporate registration certificate (limited to where a person intending to obtain permission is a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act. |
| (3) | When the Minister of Health and Welfare grants permission for a cord blood bank, he or she shall grant permission by determining the scope of business affairs according to the following classification: |
| 1. | The following business affairs of managing cord blood: |
| (a) | The donation and entrustment of cord blood; |
| (b) | The collection, testing, and registration of cord blood; |
| (c) | The manufacture, storage, quality control, and supply of cord blood; |
| 2. | The business affairs regarding the storage, quality control, and supply of cord blood. |
| (4) | When the Minister of Health and Welfare grants permission for a cord blood bank under paragraph (3), he or she shall enter the permitted matters in the ledger prescribed by Ordinance of the Ministry of Health and Welfare, and issue a certificate of permission to open a cord blood bank prescribed by Ordinance of the Ministry of Health and Welfare to the applicant. |
| Article 12 (Permission for Modification of Cord Blood Banks) |
| (1) | "Important matters prescribed by Presidential Decree" in the latter part of Article 11 (1) of the Act means any of the following: |
| 1. | The name of the cord blood bank; |
| 2. | The location of the cord blood bank; |
| 3. | The head of the cord blood bank; |
| 5. | The scope of the business affairs of managing cord blood. |
| (2) | A person who intends to obtain permission for modification pursuant to the latter part of Article 11 (1) of the Act shall submit to the Minister of Health and Welfare an application for modification (including electronic documents) prescribed by Ordinance of the Ministry of Health and Welfare, along with a certificate of permission to open a cord blood bank issued pursuant to Article 11 (4) and documents substantiating the details of modification (including electronic documents), within 30 days from the date on which a reason for modification arises. <Amended on Mar. 3, 2020> |
| (3) | When the Minister of Health and Welfare grants permission for modification, he or she shall reissue a certificate of permission to open a cord blood bank. |
| (4) | Where a person, who has obtained permission to open a cord blood bank, intends to apply for the re-issuance of a certificate of permission to open a cord blood bank because he or she has lost or damaged the certificate, he or she shall submit to the Minister of Health and Welfare an application for re-issuance prescribed by Ordinance of the Ministry of Health and Welfare (including electronic documents), along with the certificate of permission to open a cord blood bank issued pursuant to Article 11 (4) (limited to where the certificate of permission to open a cord blood bank is damaged). |
| Article 13 (Report on Closure, Suspension, or Reopening of Business of Cord Blood Banks) |
A person who intends to close, suspend, or reopen the business of a cord blood bank shall submit to the Minister of Health and Welfare a report on the closure, suspension, or reopening of the business of a cord blood bank as prescribed by Ordinance of the Ministry of Health and Welfare pursuant to Article 11 (3) of the Act along with the following documents (including electronic documents): | 1. | A certificate of permission to open a cord blood bank (limited to a report on closure or suspension of business); |
| 2. | A plan to take measures with regard to cord blood, cord blood products, and other by-products (hereinafter referred to as "cord blood, etc.") in custody and documents evidencing the completion of measures taken (applicable only to a report on the closure or suspension of business): 1 copy each. |
| Article 14 (Business Affairs of Managing Cord Blood by Persons Who Have Not Obtained Permission for Cord Blood Bank) |
"Business affairs of managing cord blood prescribed by Presidential Decree, such as medical treatment and medical test and research" in the proviso of Article 12 of the Act means the following business affairs: <Amended on March 23, 2013, March 3, 2020> | 1. | Business affairs of managing cord blood for medical treatment and medical tests of medical institutions; |
| 2. | Research approved by the institutional bioethics committee under Article 10 of the Bioethics and Safety Act (hereinafter referred to as the "institutional bioethics committee") or business affairs of managing cord blood to conduct clinical trials approved by the Minister of Food and Drug Safety under Article 34 of the Pharmaceutical Affairs Act for the diagnosis and prevention of diseases or the development of products for treatment. |
[Title Amended on Mar. 3, 2020]
| Article 15 (Business Affairs of Public Cord Blood Bank) |
"Business affairs prescribed by Presidential Decree" in Article 17 (1) 4 of the Act means performing the business affairs of managing cord blood after accepting the transfer of donated cord blood (referring to the cord blood donated through cord blood donation; hereinafter the same shall apply) from a cord blood bank that has filed a report on closure or suspension of business pursuant to Article 11 (3) of the Act, or whose permission or designation is revoked pursuant to Article 34 (1) of the Act.
| Article 16 (Procedures for Designation of Donated Cord Blood Banks) |
| (1) | A public cord blood bank defined in subparagraph 7 of Article 2 of the Act who intends to obtain designation as a public cord blood bank under Article 17 of the Act shall submit to the Minister of Health and Welfare an application for designation (including electronic documents) prescribed by Ordinance of the Ministry of Health and Welfare, along with the following documents (including electronic documents): |
| 1. | The results of examination and evaluation under Article 31 of the Act (referring to the results of the most recently conducted examination and evaluation): 1 copy; |
| 2. | A document stating the current status of facilities, human resources, equipment, and quality management systems (based on the date of application for designation); 1 copy; |
| 3. | A document stating the record of storage of newly-donated cord blood for the last 1 year, the current status of public relations activities, and the current status of human resource training: 1 copy; |
| 4. | A 5-year business plan: 1 copy. |
| (2) | The Minister of Health and Welfare, who has received the application documents under paragraph (1), shall review the details of the application and notify the review results in the form of a notice prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | A person designated as a public cord blood bank under Article 17 of the Act shall report a business plan for the relevant year and the business performance of the previous year to the Minister of Health and Welfare by January 31 of each year. |
| Article 17 (Supply of Cord Blood and Cord Blood Products) |
| (1) | A medical institution that intends to perform a cord blood transplantation by receiving donated cord blood products pursuant to Article 27 (1) of the Act (hereinafter referred to as "cord blood transplantation medical institution") shall submit a request for the supply of donated cord blood products (including electronic documents) prescribed by Ordinance of the Ministry of Health and Welfare to a cord blood bank notified of the results of search for donated cord blood products pursuant to Article 26 (2) of the Act. |
| (2) | A cord blood bank that has received a request for the supply of donated cord blood products pursuant to paragraph (1) shall transfer the donated cord blood products to the relevant cord blood transplantation medical institution by the following means: |
| 1. | Donated cord blood products shall be transported in a liquid nitrogen transportation container designed for the transport of cord blood; |
| 2. | The outer packaging shall carry cautionary notes on radiation exposure or biological contamination as well as on the cryogenic temperature of liquid nitrogen; |
| 3. | The name of the cord blood transplantation medical institution receiving the transfer of cord blood products and the name of the person in charge, the transporter, the scheduled date and time of arrival, the date and time of sealing, and the maintenance temperature shall be recorded on the outer packaging; |
| 4. | Donated cord blood products shall be kept at a temperature of -150 degrees Celsius or lower, and shall be able to maintain their frozen state until at least 6 hours later than the scheduled time of arrival. |
| (3) | A cord blood bank shall, when supplying donated cord blood products pursuant to Article 27 (1) of the Act, provide the following matters at the request of the Cord Blood Information Center under Article 23 (1) of the Act (hereinafter referred to as "Cord Blood Information Center") or a cord blood transplantation medical institution, in the absence of an unavoidable reason: |
| 1. | A copy of the cord blood collection record and a copy of the cord blood test record pursuant to Article 20 of the Act; |
| 2. | Information on anything that may affect the quality of cord blood that occurs during the collection, processing, or storage of cord blood; |
| 3. | A reference specimen necessary for a cord blood transplantation medical institution to test the compatibility for transplant; |
| (4) | A cord blood bank that intends to supply unqualified cord blood and cord blood products not discarded pursuant to Article 27 (2) of the Act shall submit to the Cord Blood Information Center a written request for approval for supply prescribed by Ordinance of the Ministry of Health and Welfare (including electronic documents), along with the following documents: <Amended on Mar. 23, 2013> |
| 1. | The purpose referred to in subparagraphs 1 and 2 of Article 9: 1 copy of the results of examination by the institutional bioethics committee on the research plan; |
| 2. | The purpose referred to in subparagraph 3 of Article 9: 1 copy of a manufacturing business permit; |
| (5) | Upon receipt of a request for approval for supply under paragraph (4), the Cord Blood Information Center shall notify whether to grant approval, as prescribed by Ordinance of the Ministry of Health and Welfare. |
| (6) | Pursuant to Article 27 (3) of the Act, a cord blood bank shall report the details of supply of cord blood and cord blood products to the Cord Blood Information Center in the form of a report (including electronic documents) prescribed by Ordinance of the Ministry of Health and Welfare within 30 days from the date of supply of cord blood and cord blood products. <Amended on Mar. 3, 2020> |
| Article 18 (Matters to Be Observed in Transboundary Transfer of Cord Blood Products) |
| (1) | A cord blood transplantation medical institution which intends to be supplied with donated cord blood products from a foreign country shall submit a written request for supply prescribed by Ordinance of the Ministry of Health and Welfare to the Cord Blood Information Center pursuant to Article 28 of the Act. |
| (2) | When cord blood products are transported between countries pursuant to Article 28 of the Act, they shall be transported in accordance with the International Air Transport Association's standards for transporting biological products. |
| Article 19 (Submission of Reports and Data) |
Pursuant to Article 30 (1) of the Act, the Minister of Health and Welfare may order cord blood banks and the Cord Blood Information Center to file a report or submit data on the following matters: | 1. | Records on matters regarding the business affairs of managing cord blood under Article 20 of the Act (hereinafter referred to as "cord blood management records"); |
| 2. | The current status of establishment and operation of database on information on donated cord blood products under Article 23 (3) of the Act. |
| Article 20 (Delegation of Authority) |
Pursuant to Article 39 (2) of the Act, the Minister of Health and Welfare shall delegate to the President of the National Institute of Organ, Tissue Blood Management the review and evaluation of cord blood banks with respect to the business affairs of managing cord blood under Article 31 of the Act. <Amended on Sep. 11, 2020>
| Article 20-2 (Processing of Sensitive Information or Personally Identifiable Information) |
| (1) | The head of a cord blood bank may process data containing information on health under Article 23 of the Personal Information Protection Act, genetic information under subparagraph 1 of Article 18 of the Enforcement Decree of that Act, and data containing resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of that Decree, if it is inevitable for performing business affairs regarding the consent to the donation and entrustment of cord blood under Article 7 (1) of the Act. |
| (2) | Where it is inevitable for performing business affairs regarding the consent to the collection of cord blood under Article 8 (3) of the Act, medical personnel who collect cord blood may process data under paragraph (1). |
| (3) | The Minister of Health and Welfare (including persons entrusted with the business affairs of the Minister of Health and Welfare pursuant to Article 23 (5) of the Act in cases falling under subparagraphs 2 through 4) may process the data referred to in paragraph (1) if it is inevitable to perform the following business affairs: |
| 1. | Business affairs regarding permission for, and reporting on, cord blood banks under Article 11 of the Act; |
| 2. | Business affairs regarding the performance of business affairs prescribed in the subparagraphs of Article 23 (2) of the Act; |
| 3. | Business affairs regarding the establishment and operation of databases under Article 23 (3) of the Act; |
| 4. | Requests for the provision of information on cord blood and the registration of information on donated cord blood under Article 24 of the Act. |
[This Article Newly Inserted on Aug. 13, 2012]
| Article 21 (Criteria for Imposition of Administrative Fines) |
The criteria for the imposition of administrative fines under Article 43 of the Act shall be as specified in attached Table 3.
ADDENDUM <Presidential Decree No. 22996, Jun. 30, 2011>
This Decree shall enter into force on Jul. 1, 2011.
ADDENDUM <Presidential Decree No. 24030, Aug. 13, 2012>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 24454, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 25840, Dec. 9, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 1, 2015.
Articles 2 through 13 Omitted.
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 29950, Jul. 2, 2019>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 30504, Mar. 3, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation: Provided, That the amended provisions of subparagraph 5 (a) of attached Table 1 shall enter into force on January 1, 2021.
Article 2 (Applicability to Application for Permission to Modification of Cord Blood Banks)
The amended provisions of Article 12 (2) shall begin to apply where a cause for modification occurs after this Decree enters into force. Article 3 (Applicability to Reporting on Details of Supply of Cord Blood and Cord Blood Products)
The amended provisions of Article 17 (6) shall begin to apply where a cord blood bank supplies cord blood and cord blood products after this Decree enters into force. Article 4 (Transitional Measures concerning Disqualification Criteria for Cord Blood and Cord Blood Products)
Notwithstanding the amended provisions of subparagraph 5 (a) of attached Table 1, the previous provisions shall apply to the disqualification criteria for cord blood collected before the enforcement date under the proviso of Article 1 of the Addenda.
ADDENDA <Presidential Decree No. 31013, Sep. 11, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on September 12, 2020.
Article 2 Omitted.
Article 3 Omitted.