UAE Healthcare / Pharma LawCabinet Resolution No. (6) of 2020 Regarding the Approval of Controls for the Operation of Cord Blood and Stem Cell Banks

Article (4) This Resolution shall be published in the Official Gazette and shall enter into force (6) six months after the date of its publication. Mohammed Bin Rashid Al Maktoum Prime Minister Issued by us: On: 14 Jumada Al-Awwal 1441 A.H. Corresponding to: 9 January 2020 A.D.

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 3 Annex 1 Controls Governing the Operation of Cord Blood and Stem Cells Banks Annexed to Cabinet Resolution No. (6) of 2020 Contents Preliminary Chapter: General Provisions 3 Definitions 3 Objectives 6 Scope of Application 6 Chapter One: Establishment Licensing Conditions 7 Licensing Procedures 8 Inspection and Audit 11 Termination of Activities 11 Authorization to Conduct Processing and Preparation Operations of New Types of Cells 12 Import and Export of Cord Blood and Stem Cells 12 Chapter Two: Regulatory and Operational Conditions 13 Chapter Three: Requirements of Quality Assurance 17 Quality Management 18 Quality Review 19 Staff 20 Used Equipment and Material 21 Establishments and Facilities 22 Documents and Records 24 Chapter Four: Monitoring of Operations 25 Donor Consent 26 Selection of Donor, Evaluation, and Testing 27 Procedures of Cell Procurement 30 Receipt of Cells by the Establishment 32 Cell Processing 33

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 4 Cell Storage and Release 33 Cell Transportation 34 Recovery Process 34 Serious Adverse Events or Reactions 35 Procedures for Cord Blood Sampling, Processing, and Storage 38 Preliminary Chapter: General Provisions Definitions State : The United Arab Emirates. Health Authorities : The Ministry of Health and Prevention, Abu Dhabi Department of Health, Dubai Health Authority, Sharjah Health Authority, and Dubai Healthcare City Authority. Committee : The Supreme Committee for Cord Blood and Stem Cells established pursuant to this Resolution. Cord Blood and Stem Cells Bank : A healthcare facility responsible for granting, collecting, testing, processing, preserving, storing, distributing, importing, exporting, and implementing the procedures related to the cord blood and stem cells, as well as other nucleated cells derived from the hematopoietic cells, such as bone marrow, peripheral blood, and cord blood. Allogenic Use : Refers to cells or tissues removed from a person and transplanted into another person. Autologous Use : Refers to cells or tissues removed from a person and transplanted back into the same person. Blood Components : Main therapeutic components of human blood (red blood cells, white blood cells, platelets, and plasma), which may be prepared through various methods, excluding lymphocytes prepared for use after transplanting hematopoietic stem cells.

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 5 Blood : The whole blood collected from a donor, which is processed either for transfusion or for any other manufacturing purposes. Cells : Individual human cells or a group of human cells when not organized in the form of connective tissue. Critical Conditions : Conditions that may affect the quality and/or safety of tissue and cells. Direct Use : Any procedure involving the donation or use of tissues that have not been previously stored. Distribution : Transportation and delivery of tissues intended for human application. Distributor : The person delegated by the establishment responsible for supervising the provision of cell or tissue transplantation services intended for distribution by such establishments. Donation : Donating cells or tissues intended for human application. Donor : Living human source of human tissues or cells. End User : The health facility, units affiliated to any hospital or institution responsible for carrying out the process of human application of cells. The end user shall obtain a license if it intends to preserve tissues for more than 48 hours. Export : The export from the United Arab Emirates to another country. Human Application : The use of tissues or cells inside or outside the recipient’s body. Import : The supply to the United Arab Emirates. Preservation : The use of chemical agents, alteration of ambient conditions, or other means during processing to prevent or delay the biological and physical deterioration of cells.

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 6 Processing : All operations carried out during the preparation, manipulation, preservation, and packaging of tissue or cells intended for human application. Procurement : The process of providing, making available, and obtaining tissues or cells. Facilities : The premises where the licensed establishments carry out their activities. Quarantine : The physical isolation of cells by any effective means while awaiting the decision on their acceptance or rejection. Quality Management : The coordinated activities followed to manage and monitor the work of the establishment with respect to matters of quality. Quality Manager : The person responsible for coordinating and monitoring the activities and ensuring the implementation of the Quality Management System. Their duties include monitoring the performance of the Quality Management System and preparing evaluation reports in accordance with a set of indicators. They are also responsible for providing consultations, training, tools, and techniques that enable the staff to achieve quality. Serious Adverse Reactions : An undesirable response, including serious complications and infectious diseases in the donor or the recipient, associated with the procurement or use of cells that are harmful or life- threatening, that cause disability or incapacity in any form, or that prolong the duration of illness and hinder the healing process. Storage : Preserving the product in a controlled and suitable environment until its distribution. Stem Cells : Cells that have the ability to self-renew and differentiate.

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 7 Self-Renewal : The ability of cells to proliferate without losing their differentiation potential and without undergoing senescence (biological aging). Self-renewal does not mean that the division of each cell results in an identical pair of stem cells, as the daughter cells may be either stem cells or more differentiated cells. Stem cells may be mature, activated, pluripotent, or unipotent. Objectives: • To define the licensing conditions for health establishments that intend to engage in any of the activities related to cord blood and stem cells, as well as other nucleated cells derived from hematopoietic stem cells, such as bone marrow, peripheral blood, and cord blood. The controls are also intended to develop a list of the necessary standards. • To define the quality and safety standards for stem cells and human tissue designated for human applications. • To provide a basis for the concerned authorities to evaluate the performance of the licensed establishments to ensure the services are provided in a safe and high-quality manner, for protecting the donors, the beneficiaries, and the public. Scope of Application: The Controls adopted pursuant to this Resolution shall include the rules and standards applicable during donation, collection, testing, processing, preservation, storage, distribution, import, export, and implementation of the procedures related to cord blood and stem cells, as well as other nucleated cells derived from hematopoietic cells, such as bone marrow, peripheral blood, and cord blood. These controls shall exclude embryonic tissues, embryonic stem cells, blood and its derivatives (except for hematopoietic stem cells), germ cells (oocytes and sperm), and human organs. These controls shall apply to all governmental and private health establishments across the State that carry out any of the activities covered by the Scope of Application and

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 8 shall be responsible for any of these activities. For the purpose of implementing this Resolution, these establishments shall be referred to as cord blood and stem cell banks. A cord blood bank may be affiliated with a health establishment or may be a stand-alone health establishment specialized solely in this field. Chapter One Establishment Licensing Conditions Licensing Authority: All establishments engaging in activities related to the use of primary human cells and stem cells shall obtain their license from the Health Authorities within whose competence they operate. Licensing Procedures: The License shall be granted after verifying the establishment’s compliance with the controls provided in this Resolution. First Step: (Application Submission) 1. Submission of a licensing application accompanied by the required documents indicated in the table below to the concerned health authority; 2. The concerned Health Authority shall forward the application to the Committee for its review; 3. The application submission fees shall be settled in accordance with the fees stipulated in this regard for the fertilization centers licensed by the Ministry of Health and Prevention, or in accordance with the fees applicable by other Health Authorities, as the case may be; 4. The Applicant shall receive an official reply with a reference number from the concerned health authority upon the completion of the application submission procedures; 5. The Committee shall review the submitted application and documents, decide thereon, and report it to the concerned Health Authority, which shall, in turn, send an official reply to the Applicant indicating the application status; 6. Duration of Procedures: shall not exceed one month.

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 9 Documents Required for Private Establishment Special Considerations A photocopy of the Owner’s and Partner’s Passport(s); (if any) Colored copies The UAE ID for the Owner and Partner (if any) (for UAE Nationals); Colored copies Authenticated Signature of the Owner, certified by the Competent Authorities; Colored copies Approval of the Department of Economic Development (DED) for the name of the Health Establishment (if applicable); Colored copies Project Presentation, accompanied by the scientific information, supported by references and research; Hard drive containing the Presentation (PowerPoint); - Proposed architectural blueprints; - Land location. Colored copy The Establishment Plan regarding: 1. Objectives. 2. Scope of application. 3. Organizational structure. 4. Administrative policy. 5. Staff. 6. Monitoring process policy. 7. Policies and guidelines for infection control. 8. Medical equipment management policy. 9. Medical waste management policy. 10. Records and documents management policy. 11. Rights and obligations of donors. 12. Quality management policy. 13. Adverse Reactions reporting policy. 14. Distribution and recall policy. One hard and one electronic copy

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 10 15. Risk assessment. 16. Accreditation plan. Second Step: (Initial Approval) 1. The initial approval fees shall be settled in accordance with the fees stipulated in this regard for the fertilization centers licensed by the Ministry of Health and Prevention or in accordance with the fees applicable by other Health Authorities, as the case may be; 2. Once the Committee approves the documents and the prescribed fees are settled, the concerned Health Authority shall send a letter of Initial Approval to the Applicant. Third Step: (Licensing) 1. Upon obtaining the initial approval, the Applicant shall complete the remaining licensing procedures with the concerned Health Authority; 2. The licensing fees shall be settled in accordance with the fees prescribed in this regard for the fertilization centers licensed by the Ministry of Health and Prevention, or in accordance with the fees applicable by other Health Authorities, as the case may be; 3. The Licensing Applicant shall provide a bank guarantee of 10 million UAE Dirhams. In case the Licensed Establishment commits a violation, an amount proportionate to the nature of the committed violation shall be deducted from this guarantee. The Licensed Establishment shall replenish the amount deducted from the bank guarantee within a period not exceeding (2) two months from the date of deduction. 4. The concerned Health Authority shall examine, inspect, and audit the Establishment in accordance with the standards and controls stipulated in this Resolution, before allowing the establishment to commence its activities. The Committee may delegate a representative thereto to participate in the examination and audit procedures, subject to prior coordination with the concerned Authority. 5. License Renewal: Upon renewal of the license, the annual license renewal fees shall be paid in accordance with the fees prescribed in this regard for the Fertilization Centers licensed by the Ministry of Health and Prevention, or in accordance with the fees applicable by other Health Authorities, as the case may be.

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 11 6. Application for Addition or Change of Activities: For the application related to adding or changing of activities, the activity change or new service addition fees shall be paid in accordance with the fees prescribed in this regard for the fertilization centers licensed by the Ministry of Health and Prevention or in accordance with the fees applicable by other Health Authorities, as the case may be. Inspection and Audit: a. The licensed establishments shall allow the Inspectors of the concerned Health Authority to carry out the supervisory role over the establishment, its facilities, equipment, products, and the processing operations performed therein; and to record observations and prepare reports on the extent of the establishment’s compliance with the conditions stipulated in this Resolution. Inspection may be carried out with or without notice. b. The frequency of inspection shall be based on the establishment’s compliance record. c. The establishment’s manager shall accompany the Inspector while carrying out their duty. The Inspector may address questions to the establishment’s staff as deemed necessary. d. The inspector shall be entitled to review any records and obtain copies thereof. e. It shall be prohibited to copy any records containing the name of a human cell donor or recipient, or any information related thereto, unless the identity has been anonymized appropriately. f. Health Authorities shall ensure that the staff responsible for inspection and assessment are adequately qualified and trained. Termination of Activities The licensed establishment shall have alternative agreements and procedures to ensure that the cells stored therewith will be transferred, in the event of suspension of the establishment’s activity for any reason (including the establishment’s closure), to another establishment(s) that is licensed to store human cells within the State. Such agreements and procedures shall be maintained in a manner that ensures the data remains accessible for 30 years after the end- use or disposal thereof.

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Cabinet Resolution of 2020 Regarding the Approval of Controls for the operation of Cord Blood and Stem Cell Banks 12 Authorization to Conduct Processing and Preparation Operations of New Types of Cells If