Clinical trials in the United Arab Emirates are authorized through a two-track system: a federal drug/clinical-trial regulator that reviews and authorizes the trial itself, and an emirate-level research ethics committee that reviews the protocol’s ethical conduct at the site. Which federal body and which ethics committee apply depends on where the trial is conducted and, as of a major 2024-2025 legal overhaul, on a regulatory transition that is still completing as of this writing. This guide covers the current federal framework — including the Ministry of Health and Prevention (MOHAP) and the newly established Emirates Drug Establishment (EDE) — alongside the Dubai Health Authority (DHA)’s ethics-review pathway, and flags what remains unsettled for sponsors planning a submission.
UAE’s Three Health Regulators, and Where Clinical Trials Fit
Healthcare regulation in the UAE is split across three separate authorities rather than run by a single national ministry: the Department of Health – Abu Dhabi (DOH) regulates healthcare in the Emirate of Abu Dhabi, the Dubai Health Authority (DHA) regulates healthcare in the Emirate of Dubai, and the Ministry of Health and Prevention (MOHAP) is both the UAE’s federal health ministry and the direct healthcare regulator for the remaining five emirates (Sharjah, Ajman, Umm Al Quwain, Ras Al Khaimah, and Fujairah), often referred to collectively as the Northern Emirates.
Clinical trial ethics review generally follows this same three-way split — DOH, DHA, and MOHAP each operate their own research ethics committee structure for facilities under their jurisdiction. Clinical trial regulatory authorization (the decision on whether the trial itself, and the investigational product, may proceed) is a separate, federal-level function, and it is this federal function that has been reorganized under new legislation that took effect between January 2025 and December 2025.
The Federal Legal Framework: Decree-Law No. 38 of 2024 and the Emirates Drug Establishment
The current federal legal basis for regulating medical products, pharmacy practice, and pharmaceutical establishments in the UAE is Federal Decree-Law No. 38 of 2024, issued 1 October 2024 and in force from 2 January 2025, replacing the earlier Federal Law No. 8 of 2019. The new decree-law substantially widened the scope of what is federally regulated, explicitly bringing clinical research entities, biobanks, and advanced therapy products into its coverage alongside pharmaceuticals, biopharmaceuticals, and medical devices.
The decree-law also formalizes the Emirates Drug Establishment (EDE) as the UAE’s dedicated federal authority for marketing authorizations, pharmacovigilance, pricing oversight, and national product-tracking systems — functions that previously sat inside MOHAP. Multiple regulatory-affairs sources report that EDE assumed a defined block of core services (reported as 44 services) from MOHAP effective 29 December 2025, including marketing authorizations, import/export permits, GMP certification, and pharmaceutical facility licensing. Because that transfer is very recent relative to this guide, sponsors should treat MOHAP-vs-EDE division of responsibility as actively settling rather than fully stable, and confirm the current authorizing body directly with mohap.gov.ae or the EDE before submitting.
A note on “the 2026 Federal Clinical Trials Law”: at the time of writing, CASRAI could not independently verify a separately-named, dedicated UAE clinical-trials law carrying a 2026 designation. The operative federal instrument covering clinical research is Decree-Law No. 38 of 2024 described above, and the most significant recent change affecting clinical-trial sponsors is the EDE’s assumption of authorization-related services from MOHAP in December 2025. If a distinctly titled 2026 clinical-trials law or implementing regulation is issued, this guide will be updated — until then, treat any specific claim of a separate “2026 Clinical Trials Law” with caution and verify directly against MOHAP/EDE primary guidance rather than secondary summaries.
The Federal Clinical Trial Authorization (CTA) Pathway
Before a sponsor can initiate a clinical trial anywhere in the UAE, a Clinical Trial Authorization (CTA) from the competent federal authority is required, alongside separate, parallel ethics-committee approval of the protocol at the site level — neither substitutes for the other, the same two-track model used across most ICH-GCP-aligned jurisdictions, including Saudi Arabia’s SFDA pathway and India’s CDSCO pathway. A CTA dossier is typically built around the trial protocol and investigator’s brochure, evidence the investigational product was manufactured under Good Manufacturing Practice (GMP), and documentation of the trial’s local personnel and sponsor/CRO arrangements.
CASRAI could not independently confirm a specific published CTA review timeline or fee schedule at the level of precision needed to state as fact here; both vary by product type and have been affected by the MOHAP-to-EDE transition described above. Sponsors should obtain current timeline and fee guidance directly from MOHAP or the EDE rather than relying on third-party summaries, particularly for any submission made in the months immediately following the December 2025 transfer of services.
Emirate-Level Ethics Review in Dubai: DHA and the DSREC
For trials conducted at facilities under Dubai Health Authority jurisdiction, ethics oversight runs through the Dubai Scientific Research Ethics Committee (DSREC), which functions as the central research ethics committee for the Emirate of Dubai and issues the final decision on health-research proposals after periodic committee review. DHA recognizes Local Ethics Committees (LECs) established within individual academic, government, semi-government, or private health institutions under its jurisdiction; where an institution has no such LEC, its research must be submitted directly to DSREC for review.
Documentation DHA/DSREC review typically expects includes: a covering letter, the DSREC application form, the study protocol or synopsis, the participant information sheet and informed consent form (required in both Arabic and English), data collection instruments, CVs for the principal investigator and co-investigators, and — for interventional studies specifically — a Clinical Trial Undertaking Letter. DHA also expects investigators on clinical trials to hold current Good Clinical Practice (GCP) certification.
Note that DSREC ethics approval is Dubai-specific: it governs research conducted at DHA-licensed sites, not the separate federal CTA decision described above, and it does not extend to research conducted in Abu Dhabi or the Northern Emirates, which fall under DOH and MOHAP respectively.
Abu Dhabi and the Northern Emirates
Sponsors running multi-site UAE trials that include Abu Dhabi facilities need separate ethics clearance through DOH’s own research governance structure, and sites in the Northern Emirates fall under MOHAP’s ethics oversight rather than DHA’s. In practice this means a single UAE-wide trial can require coordinating federal CTA authorization once, plus a distinct site-level ethics submission for each emirate-level regulator whose jurisdiction the participating sites fall under — DOH for Abu Dhabi sites, DHA/DSREC for Dubai sites, and MOHAP’s own ethics committee structure for sites in the remaining emirates.
Practical Considerations for Sponsors
- Local representation. As in most jurisdictions with a federal CTA requirement, sponsors without a UAE legal presence typically need to work through a licensed local establishment (a UAE-based sponsor entity, distributor, or CRO) to submit and hold the authorization.
- Sequence, not substitution. Federal CTA authorization and site-level ethics approval are independent requirements that both need to be satisfied before enrollment — securing one does not fast-track or waive the other.
- Build in extra lead time during the transition period. Given the EDE’s recent (December 2025) assumption of services previously handled by MOHAP, sponsors should expect some process and points-of-contact churn in the near term and confirm current submission routes before assuming last year’s guidance still applies exactly as written.
- Bilingual documentation. Participant-facing materials, notably the informed consent form, are expected in both Arabic and English.
- GCP alignment. The UAE’s clinical-trial expectations are broadly aligned with ICH-GCP principles, consistent with the country’s participation in international multi-site trials.
How This Compares to Other National Pathways
The UAE’s split between a federal product/trial authorization decision and separate, jurisdiction-specific ethics review mirrors the general two-track structure used in most ICH-aligned regulatory systems, though the specific split of federal responsibility between MOHAP and the newly formed EDE, combined with three distinct emirate-level ethics regulators (DOH, DHA, MOHAP) rather than one national ethics authority, is a more fragmented arrangement than in a single-regulator system like Saudi Arabia’s SFDA/SCTR model. Sponsors used to a single-portal system elsewhere in the Gulf or in jurisdictions like Singapore’s HSA framework should plan for the UAE’s multi-regulator structure as a distinct operational step, not an afterthought, in study start-up planning.
Frequently Asked Questions
Is MOHAP still the UAE’s clinical trial regulator?
MOHAP remains the UAE’s federal health ministry and the direct healthcare regulator for the Northern Emirates, but core drug and clinical-trial authorization functions it previously held have been transferring to the newly established Emirates Drug Establishment (EDE) since Federal Decree-Law No. 38 of 2024 took effect, with a reported significant transfer of services effective December 2025. Confirm the current authorizing body directly with MOHAP or the EDE before submitting.
What is the Emirates Drug Establishment (EDE)?
The EDE is the federal authority formalized under Decree-Law No. 38 of 2024 to centralize marketing authorization, pharmacovigilance, pricing oversight, and product-tracking functions for medical products in the UAE, including responsibilities that previously sat within MOHAP.
Does a trial in Dubai need both DHA and federal approval?
Yes. Federal clinical trial authorization (from MOHAP/EDE) and DHA’s ethics review (via a Local Ethics Committee or the DSREC) are separate, parallel requirements. Both must be satisfied before enrolling participants at a DHA-licensed site.
Is there a dedicated “2026 UAE Clinical Trials Law”?
CASRAI could not independently verify a separately-titled 2026 clinical-trials law as of this writing. The relevant current federal legal instrument is Decree-Law No. 38 of 2024, and the most significant recent operational change is the EDE’s assumption of authorization-related services from MOHAP in December 2025. Verify directly with MOHAP/EDE for the latest status.
What about clinical trials in Abu Dhabi?
Abu Dhabi sites fall under the Department of Health – Abu Dhabi (DOH)’s own research governance and ethics-review structure, separate from both DHA/DSREC in Dubai and MOHAP’s ethics oversight in the Northern Emirates.
