5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?

Yes, Federal Law No. 5 of 2019 Regulating the Practice of the Profession of Human Medicine regulates the practice of the medical profession in the UAE. Article 4 requires any person who practices the profession in the UAE (including within the free zones, according to Article 1) must be licensed to do so by a Health Authority - either the Dubai Health Authority, for Dubai, or the Department of Health, for Abu Dhabi. Article 5 provides that in order to obtain a license to practice in the UAE, a medical practitioner must hold a Bachelor’s degree or equivalent in human medicine, including dentistry, which is accredited in the State; they must have completed an internship, must be of good character and conduct, must be medically fit to perform their duties, and any other conditions or controls prescribed.

Federal Law No 8 of 2019 on Medical Products, Profession of Pharmacy, and Pharmaceutical Institutions defines a Healthcare Practitioner as a “person who is scientifically and technically qualified and licensed to practice any of the healthcare professions in the State as set out by the Implementing Regulation of this Law”.

5.2 Does local regulation require any specific documents if PI/CI is based outside the 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.

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

While the Dubai Health Authority has issued ”Guidelines for Patient Consent”, the scope of this guideline is not specific to clinical research but standard medical care and procedures. 

After consultation with the DSREC, it has been confirmed that while eConsent is not prohibited in Dubai, there is currently (as of May 2024) no specific guidance on this matter, and the acceptability of eConsent is on a case-by-case basis. Therefore, it is recommended that the Sponsor planning to use eConsent and eSignatures in a clinical trial in Dubai to discuss with authorities prior to submission.

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

Article 16.1.5 of the “Guidelines for Conducting Clinical Trials of Medicines and Medical Devices According to Good Clinical Practices of 2017 indicates the following:

“16.1.5. a copy of the document (consent) (or the record) has been provided to the subject.”

Therefore, while there is currently no indication that the consent has to be recorded, in the cases where this occurs, a copy of the recording must be given to the subject.

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

The Health Data Protection Law No. 2 of 2019 Regarding the Use of ICT [information and communication technology] in the Health Fields (Health Data Law), amended by Ministerial Resolution No. 51 of 2021 (“the Resolution”), is based on the EU GDPR law and regulates the use of information and communications technology in the health sector in the UAE. 

The Resolution provides a set of exceptions to the restriction on cross-border and the processing of UAE Health Data under Article 13 of the Health Data Law. The exceptions are set out in Article 2 of the Resolution. UAE Health Data can be exported from the UAE in the following circumstances: 

1. Treatment of overseas patients
2. Medical testing
3. Scientific research
4. Insurance claims and coverage
5. Organizations cooperating with the UAE
6. Wearables or healthcare monitoring devices
7. Pharmacovigilance reporting
8. Data approved by a Health Authority
9. Telemedicine
10. Formal request

These topics are mentioned in more detail as relevant to the topics discussed in Section 8 of this guidebook.

Violation of the Health Data Protection Law can incur a fine of between AED 500,000 to AED 700,000 (approximately USD 136,000 and USD 190,000).

Additionally, please refer to Section 8 where more information on Data Protection can be found.

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

Home delivery service of medicine was expanded by the Dubai Health Authority to the whole of the UAE during the Covid-19 pandemic, specifically to ensure that those who were most at risk for coronavirus to avoid leaving their homes. It may be assumed that home delivery of the study product may be incorporated into a clinical trial if approved by the DSREC during the application process, however, it is advisable to discuss with the MOHAP.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

From the research conducted, it is not directly specified on the websites of the relevant authorities whether participants may be compensated for purchased study products. It may be assumed that, if this is stated in an application for approval of research, it will be approved by the DSREC if acceptable.

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

Yes, the “Submissions of New Applications and Opinions to DSREC” procedure is required to be followed by applicants who seek approval to conduct a clinical trial in Dubai. The “Application Form for Ethical Approval of a Research Project” form must be completed and submitted. Question 23 of the form requires an applicant to “specify any incentives, compensation or treatment the participants will receive through participation in this study”. It may be assumed that payment to participants is permitted, and the details and amount are decided by the DSREC when considering an application.

(Refer to Question 23, on page 22 of 29.)

5.9 Specific labeling requirements for clinical study product

The Dubai Health Authority Pharmacy Guidelines indicate the requirements for labeling of medication which, it may be assumed, will also be applicable to the study product, as follows:

"Clause 13, Guideline Nine: Medication Preparation, Compounding, and Labeling

The pharmacist should ensure that all medications are properly prepared, labeled, checked, and recorded.

13.1.6. The product label must include all necessary information for appropriate administration and the initials of the persons who prepared and checked the product.

13.1.7. The final product may also include any necessary auxiliary labels, storage requirements, and expiration date.

13.3 Medications Labeling

13.3.1. Hospital/Inpatient pharmacies: all medications prepared in the facility, that are not intended for immediate dispensing to a patient, are recommended to be identified as follows:

13.3.2 Pharmacy Guidelines

1. Single-dose (unit dose) or multi-dose drugs, except parenteral solutions in which a drug has been added, should be labeled with drug name; strength; amount; dose as applicable; route of administration; expiry date; lot number, or reference code.
2. Parenteral solutions, which have added drugs contain the following information on the outer label: name of each drug; strength and amount including base parenteral solution; date and the time of the preparation; rate of infusion, Instructions for storage, handling, and administration, expiry date/BUD, the time of the admixture; lot number and the reference number or code.
3. Community/Ambulatory pharmacies: Medication prepared by the pharmacy for immediate dispensing to a patient is recommended to be identified clearly with the following information:
   1. Patient name
   2. Date of prescription fill
   3. Facility name and address
   4. Name of the prescriber
   5. Drug name
   6. Strength and dosage form
   7. Quantity dispensed
   8. Route of administration
   9. Directions for use and cautionary statements (where applicable)
   10. Expiry date of the medication
   11. Name, initials, or unique identifier of the pharmacist that filled or refilled the prescription."

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

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.

From the research conducted, no specific guidance is directly available for biologics. 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.

5.11 What is the turn-around time to get an import permit?

Within a period of 3 working days from filing an import request.

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

Yes. Dubai Health Authority does permit off-site destruction of clinical supplies, but approval is required in order to do so. Any destruction/discarding is required to be witnessed by an inspection team, rather than a certificate being required.

Dubai Health Authority’s Health Regulation Sector issued a Policy on 24 August 2021 entitled “Medications Disposal and Waste Management” that specifies the process to be followed in health and pharmaceutical facilities. 

Clause 4 sets out the requirements to be complied with, in order to dispose of drugs. Dubai Health Authority and Dubai Municipality approval is required in order to dispose of drugs through a medical waste management contractor.

Dubai Health Authority’s Health Regulation Sector: Pharmacy Guidelines

15.3. Waste Management

• 15.3.1. Medical waste should not be disposed of via the routine garbage collection system.
• 15.3.2. All expired/unusable medications, except the Narcotics, need to be returned to the drug stores from which they were purchased.
• 15.3.3. The expired/unusable Narcotic medications shall be returned to the MOHAP Central Drug Stores, after obtaining an approval letter from DHA.
• 15.3.4. The expired Controlled Drugs (CD) and Semi-Controlled Drugs (SCD) medications that could not be returned to the drug stores/authorized agent shall be discarded by the health facilities and witnessed by the DHA inspection team. For further details, refer to DHA policy for Medication Disposal and Waste Management.