What regulatory approvals are needed before a clinical trial can start in the UAE?
- No clinical trial may commence without prior approval from the Emirates Drug Establishment (EDE) and an accredited ethics committee. The EDE replaced MOHAP's Drug Control Department as the central regulatory authority for medical products and clinical research.
- Non-clinical (pre-clinical) studies must be completed before any clinical trial on humans can begin. Conducting a clinical trial without prior non-clinical data is prohibited under Federal Decree-Law No. 38 of 2024.
- In Abu Dhabi, the Department of Health (DOH) imposes additional requirements, including its own Standard on Human Subject Research and a separate ethics committee approval process.
Who this applies to
This article is for pharmaceutical sponsors, contract research organisations (CROs), clinical trial sites (hospitals, research centres), principal investigators, and medical device companies planning to conduct or participate in clinical trials in the UAE.
It is also relevant to biotech investors and licensing partners who need to understand the regulatory pathway as part of due diligence on UAE-based clinical programmes.
Entities operating exclusively within the DIFC or ADGM healthcare free zones should confirm whether their activities fall under federal regulation (they typically do for clinical trials involving human subjects) or free zone-specific rules. Clinical trials on human subjects are federally regulated regardless of where the sponsoring entity is incorporated.
The regulatory framework after the 2024 Medical Products Law
The UAE's clinical trial regulatory framework changed materially in January 2025 when Federal Decree-Law No. 38 of 2024 (the "Medical Products Law") came into force, replacing the 2019 legislation. The new law consolidates regulatory authority under the Emirates Drug Establishment (EDE), which now oversees clinical trial approvals, pharmacovigilance, and the licensing of research entities.
The EDE is now the central authority. It approves entities authorised to conduct clinical trials, issues the necessary permits, and supervises ongoing compliance. The EDE also prepares and issues the national framework for clinical and non-clinical trials, including ethical rules, procedures, and governance standards aligned with international best practice.
The Medical Products Law defines the key entities involved in clinical research. A Clinical Trial Sponsor is the individual, company, or institution that initiates, manages, and finances the trial. A Contract Research Organisation (CRO) is contracted to perform one or more of the sponsor's obligations but does not assume the sponsor's regulatory responsibilities. A Contract Site Management Organisation (CSMO) provides administrative services related to site management (researcher recruitment, feasibility assessment, patient recruitment) without bearing regulatory obligations. Contract Development and Manufacturing Organisations (CDMOs) are also recognised for the first time, reflecting the UAE's push to attract pharmaceutical manufacturing and R&D investment.
For healthcare lawyers in the UAE, the practical impact is that every clinical trial agreement must now be structured with reference to the Medical Products Law definitions and the EDE's regulatory authority, not the older MOHAP framework.
Compliance deadline. Entities and individuals covered by the new law have a one-year grace period from 2 January 2025 to comply. The deadline is 2 January 2026. Executive regulations (which will set out detailed procedures) are expected but have not yet been published at the time of writing. The existing implementing regulations under the 2019 law remain in force to the extent they do not contradict the new law.
Ethics committee approval
No clinical trial may proceed without approval from an accredited Research Ethics Committee (REC) or Institutional Review Board (IRB). The ethics committee reviews the trial protocol, informed consent documents, investigator qualifications, and the risk-benefit profile for participants.
Federal level. The EDE oversees the accreditation of ethics committees. The committee must assess whether the trial design is scientifically sound, whether participant risks are minimised and justified by potential benefits, whether informed consent is adequate, and whether vulnerable populations are appropriately protected.
Abu Dhabi. The Department of Health (DOH) operates its own Standard on Human Subject Research and requires trials conducted in Abu Dhabi to obtain DOH ethics approval. This applies to any facility or organisation conducting research involving human subjects in the Emirate.
Dubai and other Emirates. Trials in Dubai follow the federal framework administered through the EDE. Major institutional sites (Cleveland Clinic Abu Dhabi, Mohammed Bin Rashid University of Medicine, Dubai Health Authority facilities) typically have their own IRBs that operate under federal and local requirements.
The practical point for sponsors: Ethics approval is site-specific. A multi-site trial across Abu Dhabi and Dubai may require separate ethics submissions. The clinical trial agreement should specify which party is responsible for obtaining and maintaining ethics approval at each site, and what happens if approval is delayed, conditioned, or withdrawn.
The clinical trial agreement: parties and structure
A clinical trial agreement (CTA) is the contract between the sponsor (or the CRO acting on the sponsor's behalf) and each trial site. In multi-site trials, each site requires a separate CTA. The agreement governs the conduct of the trial, the allocation of responsibility, and the commercial terms.
The three core agreements
Most UAE clinical trial programmes involve three layers of contract.
The sponsor-CRO agreement (Master Services Agreement). This governs the relationship between the pharmaceutical sponsor and the CRO that manages the trial on the sponsor's behalf. It covers the scope of delegated services (monitoring, data management, regulatory submissions, safety reporting), compensation, intellectual property, confidentiality, and liability allocation. The sponsor retains ultimate regulatory responsibility even where operational tasks are delegated to the CRO.
The clinical trial agreement (CTA) between sponsor/CRO and site. This is the primary contract governing how the trial is conducted at a specific hospital or research centre. It covers the protocol, the investigator's obligations, payment terms, insurance, indemnification, data ownership, publication rights, and termination.
The investigator agreement. In some structures, a separate agreement with the principal investigator (PI) covers personal obligations, conflict-of-interest disclosures, and confidentiality. Where the PI is an employee of the site institution, the CTA typically binds both the institution and the PI.
Key commercial terms in the CTA
Payment structure. Sites are typically compensated on a per-patient, per-visit, or milestone basis. Payment schedules should reflect the actual work performed at each stage: screening, enrolment, treatment visits, follow-up, and close-out. Sponsors should avoid front-loading payments (which creates regulatory risk under anti-kickback principles) and ensure that the payment schedule is documented in sufficient detail to withstand a compliance audit.
Protocol compliance. The CTA must require the site and investigator to conduct the trial in accordance with the approved protocol, Good Clinical Practice (GCP) standards (ICH E6(R2)), and all applicable UAE laws. Non-compliance with the protocol is typically a ground for termination and may trigger clawback of payments.
Investigational product supply. The sponsor is responsible for supplying the investigational product (drug, biologic, or device) to the site. The CTA should address import permits (required from the EDE for investigational products not yet marketed in the UAE), storage conditions, accountability records, and return or destruction of unused product.
Indemnification and insurance
Indemnification is the highest-stakes clause in any clinical trial agreement. The question is straightforward: if a trial participant is harmed, who pays?
How indemnification works in UAE clinical trials
The sponsor typically indemnifies the site and the investigator against claims arising from the investigational product itself, from the trial protocol, or from the sponsor's use of trial data. This indemnity covers participant injury attributable to the product or protocol, not to the site's negligence. The standard formulation excludes claims arising from the site's failure to follow the protocol, negligence, or wilful misconduct.
Sites will seek broad indemnification from the sponsor. Sponsors will seek to narrow it. The negotiated position usually includes a carve-out for site negligence and non-compliance, a requirement for the site to notify the sponsor promptly of any claim, and the sponsor's right to control the defence of indemnified claims.
Under UAE law (Federal Law No. 4 of 2016, the Medical Liability Law), healthcare professionals are subject to medical liability for errors in diagnosis, treatment, or the conduct of medical procedures. A clinical trial investigator can face personal liability under the Medical Liability Law if they deviate from the approved protocol or fail to meet the standard of care. The CTA should address how this interacts with the sponsor's indemnity.
Insurance requirements
UAE regulatory authorities and ethics committees require clinical trial insurance as a condition of approval. The insurance must cover participant injury arising from the trial. Coverage limits are typically set by the ethics committee and vary by trial phase and risk level. First-in-human trials require higher limits than trials of approved products in new indications.
The CTA should specify which party procures the insurance (usually the sponsor), the minimum coverage limits, whether the site and investigator are named as additional insureds, and the duration of coverage (which must extend beyond the trial completion date to cover latent injuries).
Sponsors should verify that their global clinical trial liability policy extends to the UAE. Some policies exclude specific jurisdictions or require endorsement for trials conducted outside the sponsor's home territory. If coverage does not extend to the UAE, a local policy must be arranged.
Data ownership, privacy, and publication rights
Who owns the trial data?
In a sponsored clinical trial, the sponsor owns the data. This is standard internationally and should be stated explicitly in the CTA. The site has custody of source documents (patient records, case report forms) and must retain them for the period required by law, but the analysed dataset and the right to use it for regulatory submissions and commercialisation belong to the sponsor.
The CTA should address data access rights during the trial (for monitoring and auditing), data transfer mechanisms after trial completion, and the duration for which the site must retain source documents. The EDE may require access to trial records for inspection purposes, and the CTA should confirm that both parties will cooperate with regulatory inspections.
Personal data protection
Clinical trial data includes sensitive personal health information. Under the UAE Personal Data Protection Law (Federal Decree-Law No. 45 of 2021, the "PDPL"), the processing of health data requires explicit consent and is subject to enhanced protections. The CTA or a separate data processing agreement must address lawful basis for processing, data minimisation, cross-border transfer mechanisms (particularly where the sponsor or CRO processes data outside the UAE), and data subject rights. For a full treatment of cross-border data transfer requirements, see our guide on cross-border data transfers under UAE law.
Publication rights
Publication clauses generate more negotiation than almost any other provision. Sites and investigators want the right to publish. Sponsors want to control the timing and content of publications, particularly for multi-centre trials where premature or incomplete disclosure could affect regulatory submissions or commercial strategy.
The standard compromise gives the sponsor a right to review manuscripts before submission (typically 30 to 60 days), a right to request removal of confidential information, and a right to delay publication for a defined period (usually 60 to 90 days) to allow patent filings. The investigator retains the right to publish after the review period, subject to removal of confidential information. For academic medical centres, the right to publish is typically non-negotiable, and any attempt by the sponsor to impose editorial control over scientific conclusions will be resisted.
Intellectual property
IP ownership in clinical trials is more nuanced than in standard technology licensing. The sponsor owns the investigational product IP (patents on the compound, formulation, manufacturing process) and retains all rights in the trial data and results. But inventions made during the trial by the investigator or the site's research team create a potential ownership question.
The CTA should include an invention assignment or first-option clause requiring the site to disclose and, where appropriate, assign trial-related inventions to the sponsor, with fair compensation. Without this clause, the position under UAE law is less clear: Federal Law No. 11 of 2021 (Industrial Property Law) governs patent ownership, but the allocation of rights between a sponsor and an independent investigator conducting research under contract is not specifically addressed by statute. The contract must fill this gap.
Regulatory obligations during and after the trial
Safety reporting
The sponsor must have a pharmacovigilance system to collect, evaluate, and report adverse events. Serious adverse events (SAEs) must be reported to the EDE within defined timeframes: unexpected fatal or life-threatening events typically within 7 days, all other SAEs within 15 days. The CTA should require the site to report SAEs to the sponsor within 24 hours, so the sponsor can meet its regulatory reporting deadlines.
The Medical Products Law enhances pharmacovigilance requirements compared to the previous legislation, with stricter monitoring, mandatory reporting timelines, and expanded EDE enforcement powers. The precise controls and good practices for pharmacovigilance are to be further specified in a decision of the EDE board.
GCP compliance and inspections
Clinical trials must be conducted in accordance with ICH E6(R2) Good Clinical Practice guidelines. The EDE has the power to inspect trial sites, review records, and take enforcement action (including suspension or termination of the trial) if non-compliance is identified. The CTA should include cooperation clauses requiring the site to facilitate regulatory inspections and provide access to source documents.
Post-trial obligations
After trial completion, the sponsor must report results to the EDE and, where applicable, to international registries (ClinicalTrials.gov). The site must retain trial records for the period specified by law (typically a minimum of 15 years for clinical trial records, though the exact retention period under the new law awaits executive regulations). The CTA should address who bears the cost of long-term record storage, which can be significant for large multi-site trials.
Common contract issues in UAE clinical trials
What sponsors and sites should do now
Assess compliance with the Medical Products Law. The grace period expires on 2 January 2026. Sponsors, CROs, and research entities should confirm that their licensing, approvals, and internal procedures meet the new requirements. Executive regulations are pending and should be monitored.
Review existing CTAs for EDE alignment. Agreements that reference MOHAP's Drug Control Department or the 2019 law should be updated. Regulatory submission, reporting, and inspection clauses should reference the EDE and the Medical Products Law.
Confirm insurance coverage extends to the UAE. Global clinical trial liability policies do not always include the UAE automatically. Request a certificate of insurance specifically confirming UAE coverage, and check that the policy responds to claims under UAE law.
Build data protection into the CTA from the start. The PDPL applies to all health data processing. Do not rely on a generic global data processing addendum. The CTA or a UAE-specific DPA should address local requirements, including cross-border transfer mechanisms for trial data sent to the sponsor's headquarters.
Address IP ownership and publication rights clearly. These clauses are negotiated, not assumed. For trials at UAE academic medical centres, expect pushback on any restriction of publication rights beyond a reasonable review period.
Use arbitration for cross-border disputes. For multi-jurisdictional trials, ICC arbitration with a DIFC seat is a well-established mechanism. For domestic trials, DIAC is suitable. For a comparison of options, see our guide on choosing the right UAE arbitration clause.
Legal advice may be required to structure clinical trial agreements that comply with the new regulatory framework, allocate risk appropriately, and protect both the sponsor's commercial interests and the site's institutional requirements.
Update note: This article reflects the position as of March 2026. Federal Decree-Law No. 38 of 2024 (the Medical Products Law) came into force on 2 January 2025, with a one-year compliance grace period expiring 2 January 2026. Executive regulations under the new law are pending. The existing implementing regulations under the 2019 law remain in force to the extent they do not contradict the new legislation. The EDE's pharmacovigilance standards and detailed clinical trial governance rules are expected to be published separately.
External sources referenced
- Federal Decree-Law No. 38 of 2024 (Medical Products Law) (UAE Legislation portal)
- Emirates Drug Establishment (EDE official portal)
- DOH Standard on Human Subject Research (Abu Dhabi Department of Health)
- MOHAP Federal Decree-Law No. 38 of 2024 information page (MOHAP official)
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