Qatar has replaced its older, circular-based system for regulating human health research with a single statutory framework. Law No. 6 of 2025 on the Regulation of Health Research is the primary legislation, and in early 2026 the Council of Ministers issued Cabinet Resolution No. 12 of 2026, publishing the law’s executive regulations in the Official Gazette. Together, the law and its executive regulations now govern every category of human health research conducted in Qatar — including clinical trials, laboratory and biomedical research, genomic and genetic studies, collaborative international research, research involving human biological samples, and the operation of biobanks — and set out standardized legal and scientific definitions (human health research, human biological samples, serious adverse reaction, unexpected serious adverse reaction, and related terms) intended to align Qatar’s oversight with international norms.
Within the Ministry of Public Health (MOPH), the operational home for this oversight is MOPH’s research governance function, which runs Qatar’s clinical trial registration portal and reviews human-research applications (research.moph.gov.qa). This guide covers how the pathway works in practice under the new framework. It is part of CASRAI’s series on national clinical-trial regulatory pathways, alongside guides to Saudi Arabia’s SFDA pathway, the UAE’s MOHAP/DHA/EDE framework, Israel’s Helsinki Committee system, Egypt’s EDA pathway, and Turkey’s TITCK process.
The legal basis: Law No. 6 of 2025 and its 2026 executive regulations
Law No. 6 of 2025 is Qatar’s primary statute regulating health research involving human subjects, human biological material, and related data. Rather than leaving implementation detail to be worked out ad hoc, the law required a set of executive regulations to operationalize it, and those regulations were issued via Cabinet Resolution No. 12 of 2026, published in the seventh issue of Qatar’s Official Gazette for 2026. Sponsors and investigators should treat the law and the executive regulations as a single package: the law sets the statutory scope and obligations, and the executive regulations spell out the procedural detail — definitions, committee structures, documentation requirements, and enforcement mechanisms — that determine how an application actually moves through review.
Because this framework is newly issued, sponsors planning Qatar sites should confirm current procedural detail (forms, specific submission channels, fee schedules) directly against MOPH’s research governance portal before finalizing a submission timeline, rather than relying solely on secondary summaries, including this one.
Scope: what counts as regulated health research
The law and its executive regulations apply broadly to human health research conducted in or involving Qatar, including:
- Interventional clinical trials of drugs, biologics, and medical devices
- Laboratory and biomedical research using human-derived material
- Genomic and genetic studies
- Collaborative international research involving Qatar-based sites, investigators, or participants
- Research involving human biological samples
- The establishment and operation of biobanks
This is a wider scope than a narrow “drug trials only” reading of the framework — genomic research and biobanking are explicitly in scope, which matters for institutions running biorepositories or genetic-data studies that might not otherwise think of themselves as running a “clinical trial.”
The National Committee for Ethics of Health Research (NCEHR)
A companion measure, Cabinet Decision No. 13 of 2026, established the National Committee for Ethics of Health Research to oversee ethical governance and national coordination of health research activity in Qatar. The committee is chaired by MOPH and draws representation from Qatar’s major research and healthcare institutions, including Hamad Medical Corporation, Qatar University, Sidra Medicine, the Primary Health Care Corporation, and other governmental and research bodies (reported alongside national security and human-rights representation as part of the committee’s composition). For sponsors, the practical implication is that ethics oversight in Qatar now sits under an explicit national coordinating body rather than being left entirely to individual institutional review boards operating in isolation — though institution-level ethics review at sites such as Hamad Medical Corporation, Qatar University, and Sidra Medicine continues to be part of how individual protocols are reviewed at the site level.
Where applications are submitted
MOPH’s research governance function directs sponsors and principal investigators to register clinical trials on MOPH’s research registration portal, and application materials are submitted through the IRBNet platform — MOPH does not accept email or physical submissions for this purpose. Review timing is reported to vary by application category; MOPH’s published guidance distinguishes categories such as Category A, which covers multi-center clinical studies that already carry approval from a recognized authority such as the US FDA and is generally reviewed on a faster track than a first-in-Qatar or first-in-region protocol. Sponsors should confirm the current category definitions and associated review windows directly with MOPH’s research governance office at the time of submission, since categorical timelines are exactly the kind of operational detail that can be refined as the 2026 executive regulations bed in.
Documentation a submission typically requires
Consistent with an ICH-GCP-aligned framework, a complete Qatar submission package is expected to include, at minimum:
- Study objectives, scientific rationale, and methodology, including the statistical analysis plan
- The institutional review board or ethics committee approval(s) obtained at the site level
- Informed consent documentation, prepared for the languages and literacy levels of the intended participant population
- Investigator qualifications and GCP training records
- Conflict-of-interest disclosures
- Risk management and participant-protection procedures, including safety reporting arrangements for serious and unexpected adverse reactions — terms the executive regulations now define explicitly
Alignment with ICH-GCP
MOPH recognizes the standards of the International Council for Harmonisation’s Good Clinical Practice (ICH-GCP) guideline as the applicable ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects. For sponsors already running ICH-GCP-compliant programs elsewhere, Qatar’s framework is designed to be a familiar addition rather than a parallel standard requiring separate protocol design — the heavier lift is procedural (registration, IRBNet submission, and satisfying the newly defined national ethics-committee structure), not a divergent clinical standard. See CASRAI’s guide to GCP certification for background on what GCP training and certification typically involve.
What sponsors and investigators should do now
Given how recently this framework was issued, the practical checklist for a Qatar-bound protocol is:
- Confirm which regulated category the study falls under (interventional trial, genomic/genetic study, biobank-linked research, etc.) since scope now extends beyond conventional drug and device trials
- Register on MOPH’s research registration portal and prepare the IRBNet submission package early, since submissions outside that channel are not accepted
- Secure site-level ethics committee approval (e.g., at the hosting hospital or university) as a prerequisite input to the national process
- Build in contingency time for review-timeline uncertainty while the executive regulations are newly in effect, and verify current category definitions, fees, and turnaround expectations directly with MOPH rather than relying on pre-2026 procedural summaries
- Confirm biological-sample and biobanking provisions apply if the study collects, stores, or transfers human biological material, since these are explicitly in scope under the new law
Frequently asked questions
What law governs clinical trials in Qatar as of 2026?
Law No. 6 of 2025 on the Regulation of Health Research is the primary statute, with its executive regulations issued via Cabinet Resolution No. 12 of 2026 and published in Qatar’s Official Gazette. Together they govern clinical trials and other categories of human health research conducted in Qatar.
Which body reviews clinical trial applications in Qatar?
Application intake and registration run through the Ministry of Public Health’s research governance function, with ethics oversight now coordinated nationally by the National Committee for Ethics of Health Research, established under Cabinet Decision No. 13 of 2026 and chaired by MOPH with representation from institutions including Hamad Medical Corporation, Qatar University, Sidra Medicine, and the Primary Health Care Corporation.
How are applications submitted?
Through the IRBNet platform. MOPH’s research governance guidance states that email or physical submissions are not accepted for clinical trial applications.
Does Qatar’s framework cover genomic research and biobanks, or only drug trials?
It covers a broader scope than conventional drug and device trials: laboratory and biomedical research, genomic and genetic studies, research involving human biological samples, and the establishment and operation of biobanks are all explicitly within scope of Law No. 6 of 2025 and its executive regulations.
Does Qatar require ICH-GCP compliance?
MOPH recognizes ICH-GCP as the applicable ethical and scientific standard for designing, conducting, recording, and reporting human-subjects trials, so sponsors running ICH-GCP-compliant programs elsewhere are working to a familiar clinical standard even as Qatar’s procedural requirements are newly codified.
This guide reflects Qatar’s health-research framework as reported following the 2026 issuance of Law No. 6 of 2025’s executive regulations. Because the regulations are newly in force, sponsors should verify current procedural specifics — application category definitions, fees, and review timelines — directly against MOPH’s research governance portal before finalizing a Qatar submission plan.
