4. Regulatory Authority (RA)/Competent Authority (CA)

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. 

Application of clinical trial submitted to the Ministry of Health & Prevention must comply with Article 47 of the “Guidelines for Conducting Clinical Trials of Medicines and Medical Devices According to Good Clinical Practices of 2017”.

Documents New Application:

1. Administrative documentation:
   1. Fee payment confirmation
   2. Cover letter: The applicant shall submit as an attachment a signed cover letter. The cover letter should contain, the protocol number and title and a full list of all essential documents supporting the proposed clinical trial.
   3. List of Regulatory Authorities and Ethics committees apart from UAE ones, to which the application has been submitted, and information about their decisions.
   4. List of all study sites and investigators planned to participate in the UAE.
   5. Power or 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.
   6. A certified copy of the CRO license granted by the MOHAP.
2. Participant Information:
   1. Information for the patient/subject and Informed Consent Form (in English, Arabic, and any other language that will be used).
   2. Description of the procedures for obtaining informed consent from a legal representative, where applicable.
   3. Any other information that will be used for subject enrolment and/or presented to patients before or during the course of the study (in English and in Arabic). Project-specific documents for the trial subject could be any of the following:
      1. Patient diary
      2. Patient card
      3. Adverse Events diary
      4. Scales and Questionnaires (including Qualify of Life questionnaires)
      5. Calendar(s)
      6. Patient advertisement
      7. Additional trial information given in writing & / or multimedia technology to the subject
      8. Pictures of any materials intended to be given to the patient
3. Documentation concerning the trial protocol:
   1. Study protocol and all current amendments, developed in accordance with ICH-GCP requirements.
   2. Peer review of the scientific value of the trial, where available.
   3. Protocol pages signed by the Sponsor and by the investigator from each study site participating in the trial.
   4. Case Report Form.
4. Documentation about the investigational medicinal product:
   1. Investigator’s Brochure (issued not later than one year before application submission).
   2. Summary of Product Characteristics, when applicable.
   3. Outline/summary of all currently active clinical trials with the investigated product.
5. Documentation about the technical requirements and the staff:
   1. Description of the equipment and/or the technical requirements necessary to perform the Protocol procedures.
   2. Certificates for external quality assessments (for the local laboratories) or Certificates for successful accreditation procedures (for the Central laboratories). Those documents are submitted for each laboratory that will be participating in the study procedures.
   3. CV and/ or other documents confirming the qualification, experience, and training of study staff members (Investigator and Sub-Investigators).
   4. GCP training certificates of all study staff members.
   5. Financial Disclosure of Principal Investigator.
   6. Confidentiality agreement of Principal Investigator.
   7. Documents, confirming the Accreditation of the Institution.
6. Data about funding and the administrative organization of trials:
   1. Insurance covering the liability of the Sponsor and the Principal investigator(s) in case of property or non-property damages caused to the subjects related to their participation in the trial.
   2. Provision for compensation or a sample agreement between the Sponsor and study subjects, when such compensation is considered.
   3. Sample Agreement between Sponsor, Institution, and investigator, defining terms and conditions of conducting the clinical trial.
   4. Written approval Statement by the Director of the Institution regarding permission for conducting the study (if applicable).
   5. Information about a clinical trial finance resource in case the Sponsor is a non-profit organization.
   6. Pre-site assessment report signed by the Sponsor or its representative.
7. Additional documents:
   1. Investigational Product Dossier (IPD).
   2. Statement from the manufacturer, in all cases when the investigational product has a market authorization.
   3. Copy of the manufacturing authorization for medicinal products that are in the process of research and development, if the investigational product does not have a marketing authorization.
   4. Document to certify the conformity of the manufacturing conditions of the active substances of biological origin, control, and storage standards to be equivalent to the requirements of the GMP for medicinal products in a process of research and development.
   5. Results/reports from viral safety studies, where applicable.
   6. Examples of drug labels in English & Arabic, according to the requirements to the information on the packaging of medicinal products used in clinical trials.

RE- SUBMISSION (substantial Amendment):

• Cover Letter
• Application form
• Summary of the proposed amendment
• List of modified documents with their effective dates and version numbers
• Pages from the amended documents according to Appendix 02 (Initial submission) with previous and new wording
• Comments on any novel aspect of the amendment (if any)

Submission process:

1. Login to the MoHAP website or smart app using the UAE PASS.
2. Documents and the application will be reviewed by the officer in charge for the initial approval.
3. The Regulatory Committee at the Ministry of Health & Prevention will assess the application.
4. An approval letter will be issued to conduct the clinical trial.

4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process. 

Article 54. Clinical Trial Application Review by Regulatory Committee at the Ministry of Health and Prevention (RCMOHP): 

Paragraph 54.1 Within 90 calendar days of the date of submission of the application for a clinical trial of medicinal products and/or device with interventional design, the Ministry of Health and Prevention shall notify the applicant in writing that the trial: 

• 54.1.1. may be conducted on the territory of the UAE,
• 54.1.2. require some modification as a condition for obtaining a positive opinion, or 
• 54.1.3. the clinical trial to be conducted has been refused, stating the reasons for this.

Paragraph 54.2 When evaluating the documentation, the Ministry of Health and Prevention may obtain, on a one-off basis, additional documentation from the applicant within 15 calendar days from the submission. 

Paragraph 54.3 The periods under Paragraph 54.1 shall be suspended until the requested documentation has been submitted. 

Paragraph 54.4 If the applicant fails to submit an application under item 54.1.2 within the specified period of 60 calendar days, the procedure shall terminate and the clinical trial shall not take place.

4.3 Does the regulation support electronic submission?

Yes, it is an electronic submission via the MoHAP website or smart app using the UAE PASS.

4.4 Does the regulation require the applicant to be a Principal Investigator (PI)/Chief Investigator (CI)?

As a PI/CI is permitted to be the Sponsor of a clinical trial, it may be assumed that the PI/CI may act as the applicant.

4.5 Please describe the process of RA/CA submission for clinical trial approval. 

Please Sections 4.2 and 4.3 above.

4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.

The project can be tracked through the submission portal.

4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.)

The fee for reviewing a clinical trial is 5000 AED.

4.8 Does RA/CA accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Payment details are found on the MOHAP portal. The below payment methods are currently supported by MOHAP via their payment gateway:

• Credit/Debit Cards
• Bank Transfer 
• Samsung Pay
• Apple Pay

4.9 Is there any guidance tool available for making an electronic application? If yes, provide the link and/or step-by-step instructions.

The guidance available can be found on the MOHAP website under “Assessment of Medical Products for Pharmacological Research and Clinical Studies of Drugs”.

4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?

The MOHAP indicates that “additional trial information given in writing &/ or multimedia technology to the subject” must be submitted. Therefore, any participant-facing electronic information (including pictures) will need to be presented as screenshots.