2. General Questions

2.1 Name of Regulatory Authority

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

The Department of Health (DOH) is the regulatory authority of the health system in the Emirate of Abu Dhabi, at an Emirate level. The Department has established the Abu Dhabi Health Research and Technology Committee (“ADHRTC”) to oversee and support critical human subject research carried out by healthcare providers (in the areas of health-related or biomedical research, clinical trials, genomics, processing of medical data outside of the UAE, pharmaceutical/companies sponsored research, and Covid-19 Abu Dhabi-based research), and to generally advise on and promote health research in Abu Dhabi.

2.2 Name of Ethics Committee

In the Emirate of Abu Dhabi, the ethics committee for clinical research is referred to as the Research Ethics Committee or the Institutional Review Board (“REC/IRB”).

The Department of Health (DOH)'s Standard on Human Subject Research defines an Institutional Review Board as follows:

“3.21 Institutional Review Board (IRB): Is equivalent to the Research Ethics Committee (REC). It is an administrative body established within the facility that intends to conduct clinical research, to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under their facility, in addition to the legal protection for the investigators and the facility itself.”

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 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 ADHRTC. Approval must also be obtained from the REC/IRB.

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

Yes. Submission may be made simultaneously to the ADHRTC and REC/IRB for approval. 

Clinical trials with interventional design may begin when the following conditions are fulfilled: 

1. the Ethics Committee (ADHRTC and REC/IRB) has given a positive opinion, 
2. the Regulatory Committee at the Department of Health (DOH) has issued a written approval, and 
3. the Drug Control Department at the Ministry of Health and Prevention (DCD) in addition to the drug and medical product department in DOH has issued an import license. 

Steps a and b can be done in parallel; however, an import license can be obtained once all approvals have been received.

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 ADHRTC and REC/IRB on application to conduct a clinical trial in the Emirate of Abu Dhabi and approved if deemed acceptable.

2.9 Is in-country sponsor presence/representation required?

Sponsor is defined in the DOH Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices as:

“2.37: Sponsor means an individual, company, institution or organization, which takes responsibility for the initiation, for the management and for setting up the financing of the clinical trial. The sponsor should be a person established on the territory of the Emirates of Abu Dhabi with accordance of the federal law or his licensed legally authorized representative. “

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

Section 7.6 of the DOH Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices indicates the following:

“7.6- A physician or a doctor of dental medicine with suitable qualifications and license from the Department of Health - Abu Dhabi (DOH) should be responsible for the medical or dental care provided to test subjects during the clinical trial, and for making medical or dental decisions."

It is assumed that the PI has to be based in Abu Dhabi and be licensed with the DOH.

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

Within the existing DOH “Guidelines for Conducting Clinical Trials with Investigational Product and Medical Devices” and within the DOH “Standard on Human Subject Research”, there is no indication that a Chief or Coordinating investigator has to be appointed for multi-center studies in Abu Dhabi.

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? 

A CRO may be the Sponsor of a clinical trial, though it is required to have a valid DOH facility license. 

The DOH's “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” contain the following provisions:

“14. Institution & Contract Research Organization

• 14.1 The Sponsor and the investigator/institution may be the same person.
• 14.2 The Contract Research Organization involved in the clinical trial should have a valid DOH healthcare facility license.”

The DOH's “Standard on Human Subject Research” provides the following definition of a Sponsor and the accompanying obligations:

“3.10.4 Sponsor of a clinical trial: The person who takes on the ultimate responsibility for the initiation, management, and financing (or arranging the financing) of a clinical trial. Where two or more persons take responsibility for the functions of the sponsor, one of the sponsors should take responsibility for each of the following group of functions:

• 3.10.4.1 Communications relating to substantial amendments, modified amendments, and the conclusion of the trial;
• 3.10.4.2 Communications relating to urgent safety measures; and
• 3.10.4.3 Pharmacovigilance reporting.

The Principal Investigator is considered the sponsor if he/she independently plans, conducts, and is totally responsible for a clinical trial.”

It is the responsibility of the Sponsor to secure all required agreements between relevant parties, according to the Guidance of the Drug Control Department of the Ministry of Health and Preventative Medicine.

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 sets out “The obligations of the entity for whose interest the Clinical Study is conducted”, as follows:

"The entity for whose interest the Clinical Study is conducted may commit to the following:

1. Setting down a plan for the intended study, provided that it includes the scientific justifications thereof.
2. Providing licensed physicians to ensure the safety of the persons subjects in trials.
3. Concluding an insurance contract with any insurance company operating in the State, to cover the damage that may arise from the study.
4. Complying with the Good Clinical Practice Manual issued by the Ministry."

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

The DOH “Standard on Human Subject Research” indicates the following:

"5. Specific Responsibilities of Health Care Providers / Investigators with Respect to Human Subject Research

5.6 Commencement of CTIMP

5.6.4. Creating Clinical Trials Registry and include the commenced CTIMP in addition to patient’s information registry.”

“Appendix 2, Section 4. (vii)

4. The content, format and requirements to the documentation submitted to Ethics Committee (ADHRTC or REC/IRB)

a. Administrative documentation

vii Evidence of registration of clinical trial on one of the international clinical trial data system.”

Additionally, the Department of Health introduced an open COVID-19 Research Registry Platform for gathering all research activities related to the SARS-COV2 coronavirus. Submission of research studies related to COVID-19 can be emailed to medical.research@doh.gov.ae.

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)?

The DOH’s “Standard on Human Subject Research” indicates the following:

“4.3 Data and Record Keeping: A Healthcare Provider must ensure that all information related to Human Subject Research for which it is responsible is recorded, handled and stored in a way that allows its accurate reporting, interpretation, and verification in accordance with all applicable Regulations on document retention, information management and data protection and confidentiality.”

The DOH’s “Standard for Medical Record, Health Information Retention and Disposal (July 2015)” does not specify retention period for clinical trial records; however, section 4.3 indicates the following:

“4.3 All healthcare facilities are required to maintain patient medical records/health information for medical purposes for five years from the date of last treatment. 

4.3.1 While minimum retention requirements are absolute, there is nothing to prevent a healthcare facility from retaining medical records of periods well beyond the specified minimum. This may be considered appropriate for continuous treatment of UAE Nationals.”

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

DOH's “Standard on Human Research” sets forth the following for reporting requirements:

“Section 5.9- Reporting of CTIMP-Related Events

5.9.1. DOH mandates reporting of adverse events or any other pharmaceutical, medicinal and/or device related problems in accordance with the DOH Policies on ‘Reporting Adverse Reactions3’ and ‘Reporting Medication Errors4’.

5.9.2. The following occurrences should be reported to the REC and DOH:

5.9.2.1. An increase in the rate of occurrence or a qualitative change of an expected serious adverse reaction, which is judged to be clinically important.

5.9.2.2. Post-study SUSARs that occur after the patient has completed a trial and are reported by the investigator to the sponsor.

5.9.2.3. A new event, related to the conduct of the trial or the development of the IMP, that is likely to affect the safety of subjects, such as:

5.9.2.3.1. A serious adverse event which could be associated with the trial; procedures and which could modify the conduct of the trial (for example a SAE occurring during the run-in period);

5.9.2.3.2. A significant hazard to the subject population such as lack of efficacy of an IMP used for the treatment of a life threatening disease;

5.9.2.3.3. A major safety finding from a newly completed animal study (such as carcinogenicity);

5.9.2.3.4. Any anticipated end or temporary halt of a trial for safety reasons where the trial is conducted with the same IMP by the same sponsor in another country;

5.9.2.3.5. The conclusions or recommendations of a Data Monitoring Committee, where relevant for the safety of subjects.

5.9.3. Any information that materially alters the current risk/benefit assessment of the IMP or merits changes in the way the IMP is administered or the overall conduct of the trial should also be reported to the REC and DOH (DOH Adverse Drug Reaction Reporting Form).”

“Appendix 1- Guideline on SOP’s for Conducting Clinical Trials with Investigational Medicinal Products (CTIMPs)

8. Expedited Safety Reporting

1. Suspected Unexpected Serious Adverse Reactions: Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring during the trial must be notified to the Committee and the Regulatory Authority in an expedited fashion. (See DOH Adverse Drug Reaction Reporting Form5).
2. A SUSAR which is fatal or life-threatening should be reported as soon as possible and in any event after the sponsor becomes aware of the event.
3. Any additional relevant information should be reported within a specific timeline after sending the first report.
4. A SUSAR which is not fatal or life-threatening should be reported as soon as possible and in any event after the sponsor first becomes aware of the event.
5. In the case of double-blinded trials, all reports of adverse reactions should be unblended.
6. Pharmacovigilance reports may be provided to the Committee by either the sponsor, or the sponsor’s representative, or the Principal Investigator.
7. The Principal Investigator and representatives of the sponsor may be requested to attend a meeting of the Committee or Sub-Committee to discuss any concerns about the health or safety of trial participants arising from pharmacovigilance reports.”

The DOH's “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” sets forth the reporting requirements:

“Chapter XIII- Safety Follow-up and reporting as part of clinical trial

39. Reporting 

39.1 The investigator should immediately notify the Sponsor in writing, of any serious adverse event that has occurred in the course of the clinical trial with a subject in the center of which he is in charge as per the protocol. 

39.2 After the notification under item 47.1, a detailed report in writing should be submitted to the Sponsor. 

39.3 When a notification under item 47.1 or a report under item 51.2, the trial subject should be identified by a unique code specified in the trial protocol. 

39.4 The investigator should report to the Sponsor and the ethics committee all adverse events (Adverse Event of Special Interest – AESI) or laboratory deviations specified in the protocol as critical to safety, within the period and in the format compliant to the requirements of the protocol. 

40. Adverse Event: 

When the outcome of an adverse event during the conducting of a clinical trial is fatal, the investigator should be obligated to provide the Sponsor and the Ethics Committee with all additional information requested. 

41. Suspected Serious Adverse Event 

41.1 The principal investigator (PI) should notify the Ethics Committees, respectively, of any suspected unexpected serious adverse reaction that has occurred in the course of a clinical and has resulted in death or has proven to be life threatening, within seven calendar days at the latest of receiving the information about it. 

41.2 The Sponsor and principal investigator (PI) respectively should provide the bodies under item 49.1 with additional information about the case within 7 calendar days of the date on which a notification was sent. 

42. Suspected Unexpected Adverse Reaction 

42.1 The format and the content of the notifications of SUSARs (both initial as well as follow-up reports) should be submitted to the Ethic Committees along with a covering letter (printed on the company’s/ Contract Research Organization’s (CRO’s) letterhead). A template of covering letter is specified in Appendix 03. 

42.2 The Sponsor should inform the investigators carrying out the clinical trial with an investigational product of any suspected unexpected adverse reaction associated with the tested medicinal product, irrespective of its origin. 

43. Suspected Serious Adverse Reactions 

43.1 Once a year the principal investigator (PI) should submit to the REC/IRB a list of all suspected serious adverse reactions that have occurred within the past period and a report on the safety of trial subjects. 

43.2 Once a year the principal investigator (PI) should submit to the REC/IRB an update of Investigator’s brochure or other relevant information concerning the safety profile of the investigational product.“

Additionally, refer to Appendix 2: Data Elements for Reporting Serious Adverse Event (SAE) Occurring in a Clinical Trial and Appendix 3: Covering Letter Elements for Reporting SUSAR Reporting in a Clinical Trials to the Ethics Committee.

For any Pharmacovigilance inquiries, please contact the DOH team at pve@doh.gov.ae.

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 DOH's “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices” and “Standard” contain the following provisions regarding reporting as part of a clinical trial:

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

Yes. The DOH’s “Standard on Human Subject Research” provides the following regarding breaches of GCP or the protocol:

“15. Serious Breaches of Good Clinical Practice or the Research Protocol

1. The Committee should be promptly notified of any serious breach of the conditions or principles of the International Conference on Harmonization Good Clinical Practice (ICH GCP) or of the research protocol.
2. A breach should be regarded as serious if it is likely to affect to a significant degree the safety or physical or mental integrity of the subjects of the trial, or the scientific value of the trial. The sponsor should notify the Committee and the Regulatory Authority of the matter coming to their attention. There is no need to notify minor breaches of ICH GCP or the research protocol.
3. A minor deviation from the research protocol to deal with unforeseen circumstances is not considered to be a serious breach of the research protocol provided that it is approved by the Principal Investigator, either in advance or after the event. However, if the deviation would meet the criteria for a substantial amendment it should be notified to the Committee.”

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 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. A sponsor is considered to take ultimate responsibility for the financing of a clinical trial, as described in Section 2.12 above.

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.”