2. General Questions

2.1 Name of Regulatory Authority

Ministry of Health and Prevention (MOHAP), at a federal level.

The Dubai Health Authority is the regulatory authority of the health system in the Emirate of Dubai, at an Emirate level.

2.2 Name of Ethics Committee 

Dubai Scientific Research Ethics Committee (DSREC) is the central ethics committee in Dubai. It facilitates the maintenance of ethical standards during the conduct of research. It also facilitates the understanding of the principle of scientific research including research design, analysis, and methodology. Medical and non-medical professionals from the Emirate of Dubai who wish to conduct research in the health facilities under the jurisdiction of the Dubai Health Authority must obtain approval from the DSREC.

The primary objective of the DSREC is to issue ethical approval for clinical trials through independent and timely review of research projects involving human subjects in addition to ongoing ethical oversight, monitoring, and advice, to protect the mental, and physical welfare, rights, and safety of participants of research. This is in accordance with the Dubai Health Authority’s code of ethics, the ICH-GCP guidelines, and ethical principles described in the Declaration of Helsinki and the Code of Federal Regulations. Religious and cultural factors are also considered by the DSREC when making decisions.

The DSREC will issue a finding and, if an application has been approved, the recommendation will be provided to the relevant government authorities for final, official approval.

2.3 Clinical Trial Application Language

The Patient Information Sheet and Informed Consent Form must be in English and Arabic. The application may be made in English (please refer to Section 3.1 of this guidebook for a list of documentation required).

2.4 Is regulatory approval required from both regulatory authorities and/or EC?

Yes. An application for approval to conduct research must be submitted to the DSREC, which is part of the Dubai Health Authority. If the application is approved, the decision must be confirmed by the Dubai Health Authority, which then communicates the decision to the applicant/sponsor. Applications to and liaison with the DSREC take place via the Dubai Health Authority.

Applications may be made by “health care professionals who wish to conduct research in the Dubai Health Authority and health facilities under the jurisdiction of the Dubai Health Authority”.

For any drug/device under trial, all relevant pre-clinical animal data and clinical trial data from other centers (Investigators’ brochure) within the country/internationally and/or Investigational Medicinal Product Dossier (where applicable) must be submitted to the DSREC together with the documents listed in Section 3.1. The Ministry of Health and Prevention (MOHAP) is required to approve the entry of the trial drug/device into the UAE and the provision of the trial drug/device at the study site.

Depending on the type of research site, a Local Ethics Committee may also apply.

2.5 Can regulatory authority and EC submission be done in parallel?

Yes, submission to the DSREC and MOHAP can be done in parallel.

2.6 Requirement of any import permit/license before investigational product/study product is shipped from point of origin

An import license issued by the Drug Control Department at the Ministry of Health and Prevention (DCD) is required.

Approval must be obtained from the Ministry of Health and Prevention in order to import investigational/study products into the UAE. Advice may be sought from the Ministry of Health and Prevention in relation to the import and export of drugs and biological specimens via Import.Export@mohap.gov.ae.

Import license requirements can be found in the Ministry of Health and Prevention's “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices”.

2.7 Biological Specimen Export Requirements

Chapter 2 of Federal Law No. 8 of 2019 on Medical Products, Profession of Pharmacy, and Pharmaceutical Institutions sets out provisions in relation to Clinical and Non-clinical Studies in the UAE.

Article 15 states that “Clinical studies and analysis of biological specimens related to the studies may not be conducted in other than the accredited entities”, which are public and private hospitals, universities, and specialized scientific Research Centres and laboratories.

Article 51 of the Ministry of Health and Prevention “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” sets forth the requirements to obtain an export license for biological samples:

“Article 51. 

Paragraph 51.1 Only the sponsor or an authorized representative can export from the territory of the UAE to third countries all types of biological samples from clinical trials. 

Paragraph 51.2 In order to obtain export authorization (license), the person under Paragraph 51.1 shall file with the Drug Control Department at the MOHP: 

51.2.1 an application based on a model approved by the MOHP. 

51.2.2 a list of the samples and types to be exported. 

51.2.3 copy of the positive opinion of the EC (REC or LEC) and RCMOHP (if applicable). 

51.2.4 a document evidencing the payment of a fee specified in the Tariff."

The import department from the MOHAP has confirmed that any queries related to the export of biological samples can be sent to info@mohap.gov.ae. 

2.8 Are studies of GMOs permitted (e.g., GMOs used in vaccines/vaccine manufacture and other modified products)?

Federal Law No. 9 of 2020 on the Biosafety of Genetically Modified Organisms and their Products has been introduced to protect public health from potential GMO product risk. It is anticipated that the UAE will further introduce Federal law to govern products containing GMOs in line with its National Strategy for Wellbeing 2031, Vision 2021, and UAE Centennial 2071. 

Currently, UAE legislation and regulation focuses on the testing and labeling of agricultural products. It may be assumed that the proposed use of the study product containing GMOs will be assessed by the DSREC on application for approval to conduct a clinical trial in the UAE.

2.9 Is in-country sponsor presence/representation required?

Yes, Article 47.3 of the Ministry of Health and Prevention “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” indicates the following:

“Paragraph 47.3 Where the sponsor is not registered in the territory of the UAE, the application shall be accompanied by a document specifying the data about his authorized representative on the territory of the UAE.”

CROs representing the Sponsor will have to be registered and licensed by the Ministry of Health and Prevention (MOHAP).

2.10 Is there any mandatory requirement to identify a local PI or can a PI be based in a foreign country?

According to the Q&As on the “Service Catalogue” issued by the Medical Education & Research Department, page 28 indicates the following:

“Who can conduct medical research in Dubai?

The researcher must be a resident of the UAE and be physically present in order to conduct a study at the DHA or any other facilities under the jurisdiction of the DHA”.

Healthcare professionals as well as healthcare facilities must be licensed by the DHA.

2.11 Is there any mandatory requirement to identify a local chief or coordinating investigator? 

It is only required for multi-center research studies with more than 3 sites falling under the DHA jurisdiction; in these cases, a Coordinating investigator must be assigned for the study and the coordinating investigator will be the main contact point for the study.

See section 8.4 of the Submission of New Application and Opinion to the Dubai Scientific Research Ethics Committee (DSREC).

2.12 If the applicant is CRO or a third party, does regulatory authority need any authorization or transfer of obligations from the sponsor? Does the authorization letter need to be notarized and/or apostilled? 

Yes, it is required to provide the following documents for submission to the Regulatory Committee at the Ministry of Health and Prevention (RCMOHP):

• Power of Attorney or Agreement authorizing the applicant of the submission on behalf of the sponsor, in cases where the applicant is not the sponsor of the trial.
• Certified copy of the CRO license granted by the MOHAP.

There is not a template available.

2.13 Is there a requirement to register clinical trials on a local registry or database?

As part of the submission package, the MOHAP requires “Evidence of registration of the clinical trial on the clinicalTrials.gov website.” 

At a local level, the Dubai Health Authority (DHA) Research Registry enlists all research studies approved by the DSREC.

2.14 What is the local requirement for clinical study documents archival; minimum of years for the archival, specific format followed (electronic/paper and/or both)?

Dubai Health Authority’s Health Regulation Sector issued a Health Information Policy on 26 December 2022 entitled “Policy for Health Information Assets Management”. Clause 4.6 of the Policy sets out the following storage requirements for the storage of data related to clinical trials:

“Advanced Clinical Trial master files of Investigational Medicinal/Clinical Devices Products; and Trial Subject’s Medical Files:

• Thirty (30) years after the conclusion of the trial.
• Documents can be retained for a longer period, however, if required by the applicable regulatory requirements or by agreement with the Clinical Trial Sponsor.
• There should be a flag or divider in health records for documents pertaining to research indicating that the Data Subject/Patient has been recruited to a clinical trial or other research.
• It is the responsibility of the Clinical Trial Sponsor and chief Investigator to ensure that documents are retained.

Research Ethics Committee Records and minutes of meetings relating to a clinical trial:

• Where the trial proceeds, at least five (5) years from the conclusion of the trial.
• Where the trial does not proceed, at least five (5) years from the date of the opinion.

Research Ethics Committee Records and minutes of meeting relating to a non-clinical investigation:

• Three (3) years from date of decision.”

DHA Standard for Telehealth Services, Standard Five:

“9.4. Accessibility and retention of health records must be consistent with applicable Federal and local laws and regulations.

9.4.1. Information, communication, and technology data should be maintained for a minimum of twenty-five (25) years from the date of the last health encounter.”

2.15 Requirements around periodic safety reporting and timelines on SAEs/AEs/ADRs/SUSARs/DSURs.

The DHA has issued an SOP for the Monitoring of Clinical Studies. The following provisions are specified in clause 8.3 in relation to the handling of adverse events:

1. Reporting guidelines for both National and Foreign adverse drug reactions:

Chapter 2 of Federal Law No. 8 of 2019 on Medical Products, Profession of Pharmacy, and Pharmaceutical Institutions sets out federal law in relation to Clinical Studies. Article 19 specifies the obligations of the chief researcher and the entity for the Clinical Studies, as follows:

“The principal researcher supervising the conduct of Clinical Studies and the site in which the research is carried out, shall comply with the study plan and the approved Good Clinical Practices Manual, and notify the entity for whose interest the Clinical Study is performed, the chairman of the sub-committee at the accredited entity referred to in Article 18 of the present Law, the Ministry or the Relevant Authority, as the case may be, in any of the following cases:

1. The occurrence of a Serious Adverse Event during the study provided that the notification is made within fifteen (15) days at most from the date of knowledge of the event.
2. Prior to any changes in the study plan to protect the persons, subjects of the study, or in case of urgency, at the time of change.
3. Providing notice of the request that has resulted in the cessation of such study and the withdrawal of any person who is a subject in the study.”

2.16 Requirement on any periodic clinical study update, specific template, and its frequency (e.g., interim or annual progress report and final report, etc.)? 

The Dubai Health Authority has issued an SOP for the Monitoring of Clinical Studies. The following provisions are specified, in clause 8.2, in relation to the monitoring of clinical research:

“The DSREC will monitor approved projects to ensure compliance with its ethical approval. In doing so, it may request and discuss information on any relevant aspects of the project with the investigators at any time.

Monitoring of approved projects by the DSREC will be through the following:

• Annual Progress Reports submitted by the Principal Investigator.
• Notification of study completion at the end of the study.
• Clinical Study Report, when available.
• Ongoing Reporting of safety Information, if any.
• Major Protocol deviations affecting patients’ safety, if any, should be informed with adequate justifications.
• Random inspections by DSREC of research sites, data, and signed consent forms.
• Interview, with their prior consent, of research participants.
• Progress Reports should include, as a minimum, the following information:
  • Dates of site initiations
  • Number of patients recruited at the time of writing the report
  • Targeted number of patients on site
  • Expected end of recruitment
  • Any major safety events
  • Any other important information
• Final Investigational Product reconciliation and destruction applies only to the End of Study Report.

The DSREC shall require, as a condition of approval of each project, that investigators immediately report anything that might warrant a review of ethical approval of the protocol, including:

• Proposed changes in the protocol;
• Any unforeseen events that might affect the continued ethical acceptability of the project; and
• New information from other published or unpublished studies which may have an impact on the continued ethical acceptability of the trial, or which may indicate the need for amendments to the trial protocol.
• The DSREC shall require, as a condition of approval of each project, that investigators inform the DSREC, giving reasons, if the research project is discontinued before the expected date of completion.
• Where the DSREC is satisfied that circumstances have arisen such that a research project is not being or cannot be conducted in accordance with the approved project, the DSREC may withdraw approval. In such circumstances, the DSREC shall inform the principal investigator and the institution of such withdrawal of approval in writing, and recommend to the institution that the research project be discontinued, suspended, or that other necessary steps be taken.

In determining the frequency and type of monitoring required for approved projects, the DSREC will give consideration to the degree of risk to participants in the research project.”

Submission Type: Using Study-specific Reporting form OR DHA form Appendix 3.1: Study Site Progress/Annual Report Template – Monitoring of Clinical Studies. To be sent via email or handed to Dubai Health Authority as hardcopy.

2.17 Does the local regulation require notification of “serious breaches” of GCP or the trial protocol? 

Yes. Chapter 2 of Federal Law No. 8 of 2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions sets out federal law in relation to Clinical Studies. Article 19 specifies the obligations of the chief researcher and the entity for the Clinical Studies, as follows:

“The chief researcher supervising the conduct of Clinical Studies and the entity in which the research is carried out, shall comply with the study plan and the approved Good Clinical Practices Manual, and notify the entity for whose interest the Clinical Study is performed, the chairman of the sub-committee at the accredited entity referred to in Article 18 of the present Law, the Ministry or the Relevant Authority, as the case may be, in any of the following cases:

1. The occurrence of a Serious Adverse Event during the study provided that the notification is made within fifteen (15) days at most from the date of knowledge of the event.
2. Prior to any changes in the study plan to protect the persons, subjects of the study, or in case of urgency, at the time of change.
3. Providing notice of the request that has resulted in the cessation of such study and the withdrawal of any person who is a subject in the study.”

2.18 Does RA/CA require insurance and indemnity to cover the sponsor and investigator’s potential liability?

Yes, the DSREC, on review of an application for approval to conduct research, will determine whether or not to approve the proposal of the sponsor in relation to insurance coverage, indemnities, or other forms of compensation in the case of injury or death of participants.

Chapter 2 of Federal Law No. 8 of 2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions sets out provisions in relation to Clinical and Non-clinical Studies in the UAE.

Article 16 requires “the entity for whose interest” a clinical study is conducted to commit to concluding “an insurance contract with any insurance company operating in the State, to cover the damage that may arise from the study.”

Clause 8 of the Undertaking Letter to Conduct Human Subjects Research requires an applicant for approval to conduct clinical research to certify that the “facility/facilities hold appropriate human subjects research indemnity insurance covering all adverse outcomes for individuals who are the subject of the research, all other potential liabilities of the Institution, and all potential liabilities of individual clinicians and researchers employed by, or contracted to, the Institution.” The exact amount of insurance and indemnity required by DSREC is not specified.

Articles 11 (4) and 12 of the Ministry of Health and Prevention “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices set forth the following:

“Article 11 (4): A clinical trial may commence and shall be carried out where: An insurance or compensation covering investigator or sponsor liability has been ensured.

Article 12: The sponsor and the investigator shall make a local insurance covering their liability available to the trial subjects in the event of any trial-related injury or death during the course of the trial.”