Bringing stem cell innovation to Qatar, whether for clinical research, therapeutic applications, or future commercialization, requires a clear understanding of the country’s regulatory landscape, ethical frameworks, and infrastructure requirements. Raf Healthcare Consultancy is here to walk you through every step: from facility registration and IRB approval to Ministry of Public Health (MoPH) authorization, data management, and post‑approval monitoring.

Why Qatar?

Qatar’s National Vision 2030 and Healthcare Transformation

• Vision 2030
  Qatar’s long‑term development plan prioritizes a modern, diversified economy built on knowledge‑based industries. The healthcare sector is earmarked for cutting‑edge research and high‑quality care.
• Healthcare Transformation
  Under the National Health Strategy, Qatar is investing heavily in Precision Medicine and Regenerative Medicine to reduce reliance on imported services, improve patient outcomes, and position Doha as a medical research hub.

Precision Medicine & Regenerative Medicine in the Middle East

• Regional Leader
  Qatar is among the first Gulf countries to adopt a nationwide approach to precision health—collecting genomic data (via Qatar Biobank) and fostering partnerships with global biotech firms.
• Stem Cell Focus
  Sidra Medicine, Hamad Medical Corporation (HMC), and Qatar Foundation have all initiated pilot studies exploring adult stem cells for hematological diseases, cord blood banking, and iPSC derivation.

Key Players

• Sidra Medicine
  A state‑of‑the‑art women’s and children’s hospital with an active research wing. Has capacity for advanced cell processing.
• Hamad Medical Corporation (HMC)
  Qatar’s largest public healthcare provider and research sponsor. Houses the Medical Research Center (MRC) and MoPH‑registered IRBs.
• Qatar Biobank
  Provides access to population‑based genomic and biobanking data—essential for translational research.
• Qatar Foundation
  Invests in biotech startups, offers funding through programs like the World Innovation Summit for Health (WISH).

Government Support

• Biomedical Research Funding
  MoPH and the Qatar National Research Fund (QNRF) offer competitive grants for early‑stage stem cell projects.
• Innovation Zones
  Qatar Science & Technology Park (QSTP) provides laboratory space, incubator facilities, and regulatory guidance.
• Clinical Trial Acceleration
  In 2023, MoPH introduced a fast‑track review process for first‑in‑region regenerative medicine trials to shorten approval timelines.

Global Innovation Ranking

In 2024, the Global Innovation Index ranked Qatar 49th globally, reflecting the government’s sustained investment in healthcare R&D, which is driving rapid growth in regenerative medicine capabilities.

Overview of the Stem Cell Market in Qatar

Current Clinical Use

• Bone Marrow Transplantation
  HMC performs ~100 allogeneic transplants per year, sourcing stem cells from both local and imported donors.
• Cord Blood Banking
  Qatar Cord Blood Bank (QF‑supported) has stored over 3,000 units since 2015; ~10 transplants performed to date.

Ongoing Trials & Registered Studies

• ClinicalTrials.gov (2024)
  • “Safety of Autologous Mesenchymal Stem Cells in Cardiac Repair” (Sidra Medicine).
  • “Feasibility of iPSC‑Derived Neural Progenitors for Spinal Cord Injury” (HMC MRC).
• MoPH Registry (2025)
  Includes 5 trials—three exploring mesenchymal stromal cells (MSCs) for osteoarthritis, one on adipose‑derived SVF for diabetic foot ulcers, and a pediatric thalassemia study using cord blood.

Key Institutions Involved

• Research Institutions
  HMC Medical Research Center, Qatar University Biomedical Research Center, Weill Cornell Medicine‑Qatar.
• Private Sector
  A handful of private hospitals (e.g., Al Ahli Hospital) have applied for MoPH research site approval but have not yet started stem cell trials.

Commercial Applications to Date

• Hematology
  Routine use of hematopoietic stem cell transplants for leukemia and lymphoma.
• Orthopedics (Off‑Label)
  Select private clinics market MSC injections for osteoarthritis, though formal MoPH‑approved trials are still underway.
• Future Potential
  Growing interest in neurodegenerative diseases (Parkinson’s, ALS), autoimmune diseases (multiple sclerosis), and gene‑edited iPSCs for rare disorders.

What Is Allowed and Not Allowed in Qatar? (Stem Cell Policy Breakdown)

Permitted Stem Cell Types

1. Adult Stem Cells
   • Bone Marrow & Peripheral Blood (for hematopoietic applications).
   • Adipose‑Derived MSCs (e.g., fat‑derived stromal vascular fraction).
2. Induced Pluripotent Stem Cells (iPSCs)
   • Reprogrammed from adult somatic cells. No ethical concerns tied to embryo use.
3. Cord Blood & Placenta Stem Cells
   • Collected at birth; must be banked or used under IRB‑approved protocols.
4. Leftover IVF Embryos
   • Can be used only if :
     (a) originally created for reproduction
     (b) no longer needed by the donor couple
     (c) fertilized egg is ≤6 days old
     (d) not implanted
     (e) not used for profit.
5. Miscarriage‑Derived Stem Cells
   • Fetal tissue from spontaneous or medically indicated miscarriages (with consent).

Prohibited Activities

• Creation of Embryos Solely for Research
  Creating embryos (blastocysts) solely to extract stem cells is not allowed.
• Somatic Cell Nuclear Transfer (Therapeutic Cloning)
  Somatic Cell Nuclear Transfer for stem cell research is strictly prohibited.
• Human‑Animal Chimeras
  Cannot introduce human embryonic or pluripotent stem cells into non‑human blastocysts.
• Breeding Animals with Human Genetic Contribution
  Germline alterations that cross species (e.g., breeding animals with human genes) are banned.
• Importing Unethically Derived Embryonic Stem Cells
  Embryonic cells derived through embryo destruction or from countries with lower ethical standards are banned.
• Commercial Use of Embryonic Stem Cells
  Direct sale or profit is prohibited unless part of a MoPH‑approved clinical trial.
  
  

Who Can Apply to Conduct Stem Cell Research or Therapy in Qatar?

Public Hospitals & Research Centers

• Hamad Medical Corporation (HMC) Medical Research Center.
• Sidra Medicine Research Division.
• Weill Cornell Medicine‑Qatar.
• Qatar University Biomedical Research Center.

Private Clinics & Hospitals

• Must obtain a full Healthcare Facility License (Department of Healthcare Professions).
• Must establish or partner with a MoPH‑registered IRB.
• Must secure MoPH approval for each stem cell research or therapy protocol.
• Facilities involved in cell processing must comply with GMP standards.

Contract Research Organizations (CROs)

• CROs already conducting drug or device trials can expand into stem cell protocols with MoPH approval.
• Must work with a MoPH‑registered IRB and meet all documentation requirements.

Universities & Academic Institutions:

• Faculty‑led research groups may submit protocols via their institution’s IRB.
• All studies require MoPH authorization prior to initiation.

International Biotech Firms (Foreign Entities)

• Must collaborate with a local, MoPH‑approved sponsor institution (e.g., HMC or Sidra).
• Local sponsor assumes responsibility for IRB oversight, participant safety, data integrity, and MoPH regulatory compliance.
• Direct independent applications by foreign entities are not permitted.
  
  

Legal Pathways to Approval

Registering as a Recognized Research Facility

Step 1: Obtain a Healthcare Facility License

• Apply through the Department of Healthcare Professions (DHP) within MoPH.
  • Submit facility details: location, infrastructure, staffing.
  • Demonstrate compliance with MoPH Facility Requirements (sterile rooms, CLIA‑equivalent labs, trained personnel).
• Infrastructure & Safety Standards
  • Adequate space for cell culture labs (Class II biosafety cabinets, cleanrooms).
  • Waste disposal systems for biohazardous materials.
  • Emergency response plan for adverse events.
  • Electronic Medical Records (EMR) integration with research data capture.

Step 2: Establish an Institutional Review Board (IRB) or Partner with an Existing One

1. Option A
   Form Your Own IRB
   • Composition: ≥5 members, including:
     • Medical specialist (e.g., hematologist, cell biologist).
     • Ethicist/bioethicist.
     • Legal expert (health law background).
     • Community representative (non‑scientist).
   • Terms of Reference (ToR)
     • Frequency of meetings (monthly recommended for first year).
     • Quorum definition (minimum 3 members).
     • Protocol submission deadlines (e.g., 4 weeks before meeting).
     • Conflict of interest policies.
   • Submit IRB Registration Package to MoPH
     • Documents Required
       • IRB ToR (signed by hospital leadership).
       • CVs of all IRB members.
       • Institutional Assurance (ethical compliance statement).
       • Facility map showing dedicated “Research Oversight Office.”
   • MoPH Review & Approval
     ~4–6 weeks for first‑time IRB.
   • Post‑Approval
     Maintain records, minutes, annual reports, member training logs.
     
     
2. Option B
   Partner with an Established IRB
   • Formal Agreement/Memorandum of Understanding (MoU)
     • Define scope: which protocols the local clinic submits vs. IRB reviews.
     • Cost structure (per‑protocol review fees, administrative charges).
   • Submit MoU & Institutional Assurance: to MoPH for recognition of the partnership.
     
     

IRB Approval Process (Step-by-Step)

1. Pre‑Submission Consultation (Optional but Recommended)
   • Schedule a meeting with the chosen IRB office (HMC MRC, Qatar University or Sidra).
   • Present your concept and high‑level protocol outline for initial feedback.
2. Compile IRB Application Package
   • Research Protocol
     • Use the HMC Research Protocol Template:
       • Download HMC Protocol Template (DOC)
     • Sections to complete: Introduction, Background & Rationale, Objectives (primary & secondary), Study Design (randomized, open‑label, etc.), Inclusion/Exclusion Criteria, Sample Size Calculation, Intervention Details, Outcome Measures, Statistical Analysis Plan, Budget, Timeline.
   • Investigator CVs & Licenses
     • All co‑investigators (physicians, lab scientists) must provide CVs, medical licenses (or academic credentials for non‑MDs), and any relevant certifications (e.g., GCP), and CITI Program Certification.
   • Informed Consent Forms
     • Download and adapt the MoPH Informed Consent Template from the MoPH Human Research portal.
     • Must include: study purpose, procedures, risks/benefits, confidentiality, voluntary participation, data usage, potential commercialization disclosures (if applicable).
   • Data Confidentiality & Security Plan
     • Outline how patient data will be captured (electronic REDCap or comparable system), de‑identification methods, storage location (encrypted servers), and data access logs.
   • Budget & Funding Documentation
     • Detailed cost breakdown: personnel (PI, research coordinators, lab techs), consumables (media, reagents), equipment (bone marrow aspirator, centrifuge), participant compensation (if any), insurance.
   • Site‑Specific Documents
     • Facility Training Logs (GCP, biosafety,CITI).
     • Lab SOPs (Good Cell Culture Practices, sample handling).
     • Institutional Biosafety Committee (IBC) approval (if biohazardous materials are involved)
     • Emergency Response Plan (for adverse events in cell therapy).
     • Letters of Support from collaborating institutions (if applicable).
3. Submit Application to IRB
   • Ensure all forms are signed (PI, Department Chair, Quality Assurance).
   • Include a Cover Letter briefly summarizing the study and listing attachments.
   • IRB application fee (varies by institution; typically QAR 5,000–10,000 per protocol for private or industry-sponsored studies; fees may be waived for academic research).
4. IRB Review Cycle
   • Initial Screening (Within 2 Weeks): IRB Administrator checks completeness.
   • Full Board Review (Within 4–6 Weeks): IRB panel meets; protocols with stem cells usually require a full board review rather than expedited.
   • Possible Outcomes
     • Approved with no changes.
     • Approved with minor/moderate modifications (respond within 2–4 weeks).
     • Deferred for major revisions.
     • Rejected (rare, but can occur if ethical or safety issues are irreconcilable).
   • IRB Approval Letter: Official document with protocol number, approval date, expiration date (typically 1 year).
5. Post‑Approval Requirements
   • Annual Continuing Review
     Submit progress report, number of subjects enrolled, adverse events summary.
   • Amendments
     Must be submitted and approved before implementing any changes to protocol, consent forms, or data collection procedures.
   • Adverse Event Reporting
     Serious unexpected events (SAEs) must be reported within 24–72 hours, depending on severity.

Applying to the Ministry of Public Health (MoPH)

Once you have IRB approval, the next step is formal MoPH authorization.

1. Determine If Recombinant DNA Advisory Committee (RAC) Review Is Needed
   • If your protocol involves genetic modification (e.g., CRISPR‑edited iPSCs), submit to MoPH’s RAC.
   • Standard stem cell therapies (e.g., hematopoietic or MSC transplants) do not require RAC review unless genetic engineering is involved.
   • Provide:
     • Detailed genetic engineering methods.
     • Biosafety level classification (BSL‑2 vs. BSL‑3).
     • Risk mitigation strategies (vector containment, personnel training).
2. Compile MoPH Submission Package
   • IRB Approval Letter (scanned, signed, dated within the last 3 months).
   • Complete Protocol (same as IRB version; include amendments).
   • Investigator Brochures (literature summaries for any investigational products).
   • Informed Consent Form (MoPH‑approved template).
   • Data Safety Monitoring Plan
     • Identify Data Safety Monitoring Board (DSMB) members, meeting frequency, stopping rules.
   • Institutional Assurance Form: Statement confirming facility adherence to MoPH research policies (signed by CEO or Medical Director).
   • Insurance/Indemnity Certificates
     • Required for commercial trials (QAR 100,000+ coverage per subject).
     • Academic/non-commercial studies are exempt under MoPH policy.
   • Letter of Support/No Objection
     • From Ministry of Defense (if trial involves military personnel) or other stakeholder bodies, if applicable.
     • GMP Certification: For any facility processing stem cells, provide evidence of GMP compliance.
3. Submit via MoPH Clinical Trial Portal
   • URL: https://research.moph.gov.qa/en/Pages/HumanResearch.aspx
   • Create an account or use existing credentials.
   • Upload all documents in PDF format, ensuring file names match MoPH guidelines (e.g., “Protocol_V1_2025‑05‑20.pdf”).
   • Pay MoPH processing fee (QAR 15,000–25,000 for commercial trials; academic studies are fee-exempt).
4. MoPH Review Timeline
   • Initial Completeness Check (2 Weeks)
     If missing documents, you will be asked to submit them.
   • Scientific & Ethical Review (4–8 Weeks)
     MoPH committee reviews safety, ethical compliance, and national priorities. Gene-editing trials may require 6–12 weeks due to additional RAC review.
   • Final Decision:
     • Approved: You receive an official MoPH Authorization Letter with a unique study number (e.g., “QSTP/IRB/2025/SC001”).
     • Conditional Approval: You may need to address minor queries (e.g., refine inclusion criteria, clarify lab SOPs).
     • Rejected: Only if non‑compliance with MoPH policy, unresolved ethical concerns, or public health risk.
5. Post‑Authorization Obligations
   • Annual Renewal
     Submit interim reports—participant enrollment, safety data, protocol deviations.
   • Amendment Submission
     Any change (new recruitment site, dosage modification) requires MoPH notification and approval—timeline ~4 weeks.
   • Study Closure Report
     Upload final data, including summary of outcomes, SAEs, and final numbers enrolled within 90 days of study end.
   • For multinational studies, include foreign IRB approvals and data transfer agreements as required.
   • Outline post-trial access plans for participants, if applicable, in line with ISSCR recommendations.

Required Documents and Templates

Below is a consolidated list of documents you will need, along with direct download links or resources.

Import & Lab Compliance

Can Stem Cells Be Imported?

• Permitted if:
  1. Source cells comply with Qatar’s ethical standards (no banned embryo sources).
  2. Donor consent was obtained and documented.
  3. Cells are accompanied by a Material Transfer Agreement (MTA) specifying permitted uses.
  4. Import license and clearance obtained from:
     • Ministry of Environment & Climate Change (MECC) for biological material import permits.
     • Qatar Customs (clearance certificate).

License for Import of Biological Material

1. Apply to MECC:
   • Documents Needed:
     • MTA (signed by both sending and receiving institutions).
     • Ethics approval letter (from IRB).
     • Biosafety Cabinet Certification.
     • Freight details (IATA packaging, cold chain plan).
   • Timeline: 3–4 weeks.
2. Customs Clearance:
   • Provide MECC permit, export documents from origin country, and invoice (even if no cost).
   • Ensure “HS Code 3002.49” (Cell preparations) is indicated on shipping documents.

Is a GMP Facility Required?

• Clinical‑Grade Cell Processing:
  • Any stem cell product intended for human infusion must be prepared in a GMP‑certified cleanroom (ISO Class 7 or better) with ISO Class 5 biosafety cabinets or isolators.
  • Certification Bodies: Qatar does not yet have a local GMP‑certification body; most labs follow EU GMP Annex 1 or US FDA cGMP guidance.
  • Lab Accreditation: Work with Qatar Metrology Institute or international auditors (e.g., SGS, TÜV Rheinland) to certify your cell processing lab.
• Quality Control Testing:
  • Viability assays (e.g., trypan blue exclusion, flow cytometry).
  • Sterility (mycoplasma, endotoxin) testing outsourced to an ISO/IEC 17025 testing lab if your facility cannot do in‑house.
  • Karyotyping (for iPSC products).
  • Certificate of Analysis (CoA) for each batch—stamped by QC manager.
    
    

How Long Does the Approval Take?

Fast‑Track Options:

• MoPH offers “Priority Review” for studies aligned with national health priorities (e.g., pediatric thalassemia, COVID‑19 complications).
• Demonstrate co‑sponsorship from a recognized institution (e.g., Sidra) to accelerate both IRB and MoPH reviews.
• Pre‑submission meetings with IRB & MoPH can reduce back‑and‑fort
  
  

Common Scenarios & Client FAQs

Below are frequently asked questions we encounter when consulting with clients on stem cell research in Qatar. Prepare these answers to address customer concerns proactively.

Ongoing Monitoring and Reporting. Ongoing Monitoring and Reporting

Adverse Event Reporting

• Local IRB Notification:
  • Serious Adverse Events (SAEs) must be reported within 24–72 hours—per IRB guideline.
  • Non‑Serious Events: Summarized in the Annual Continuing Review.
• MoPH Notification:
  • Any event causing death, permanent disability, or unexpected hospitalization must be reported within 72 hours.
  • Submit a “Safety Update Report” with aggregate data if multiple sites are involved.

Annual Continuing Review

• Due 30 Days Before IRB Approval Expiration:
  • Enrollment figures (number screened vs. enrolled).
  • Adverse event summary.
  • Protocol deviations or violations.
  • Updated consent forms (if modified).
  • Updated CVs (if any investigators changed).

Amendments & Protocol Changes

MoPH Approval: All amendments affecting safety or primary outcomes must be submitted to MoPH—anticipated 4‑week review.

Minor Amendments: (e.g., logistics, labeling updates) Usually processed within 2–3 weeks.

Major Amendments: (e.g., change in dosage, new recruitment site, revised inclusion/exclusion criteria) Require a full IRB review—4–6 weeks.

Final Study Closure Report

Deadline: Within 90 days of last patient’s last visit.

Contents:

• Final enrollment numbers.
• Primary and secondary outcome summaries.
• Comprehensive safety overview (all SAEs, withdrawals).
• Any deviations, protocol compliance summary.
• Plans for data archiving (per MoPH guidelines, typically 5 years).

Why Now Is the Time to Bring Stem Cell Therapy to Qatar

• Strategic Location & Regulatory Openness: Qatar’s leadership has signaled strong support for regenerative medicine—making it one of the most straightforward Gulf countries to launch early‑phase stem cell studies.
• Untapped Clinical Demand: While bone marrow transplants and cord blood banking exist, there is a significant gap in advanced MSC and iPSC trials—providing a first‑mover advantage.
• Rising Investment in Healthcare R&D: Government funding, coupled with QSTP’s incubator programs, reduces entry barriers for startups and established biotech firms alike.
• Positioning Qatar as a Global Biotech Hub: By conducting rigorous, MoPH‑approved clinical trials, you help Qatar climb international rankings and attract further investment.

Raf is a leading healthcare consultancy company in Qatar. If you’re looking to set up stem cell research or therapy services, contact us at +974 3012 9064. We provide end-to-end solutions tailored to the unique needs of clinics, medical facilities, and corporate clients.