Abu Dhabi (UAE)

DCT Feasibility Assessment Abu Dhabi (UAE) The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Discl...

Abu Dhabi is one of seven autonomous Emirates in the Federation of the United Arab Emirates (UAE). The highest legislative body in the UAE is the Federal Supreme Council which is comprised of seven members, one for each Emirate. The biotechnolo...

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 Departmen...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. The following documentation is required to be submitted to the Abu Dhabi Health Research and T...

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. First of all, all Healthcare facilities, Academic Institutes, CROs, and Government/Private instit...

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 Human Medicine regulates the medical profession in the UAE. Article 4 require...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Article 51 of the Ministry of Health and Prevention’s “ Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devic...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? The use of DCT elements may be considered on a case-by-case basis. The Department of ...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The Personal Data Protection Law, Federal Decree Law No. 45 of 2021 regarding the Protection of Personal Da...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? From the research conducted, it could not be established whether digital adve...

10.1 Clinical Trial with Investigational Medicinal Product DOH’s “ Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices ” 10.2 Pediatric Investigation Plan (PIP) From the research conducted, n...

Federal Legislation, Regulations and Guidance Ministry of Health and Prevention https://mohap.gov.ae/   Abu-Dhabi Department of Health https://www.doh.gov.ae/en/   Abu-Dhabi- DOH- Standard on Human Subject Research https...

None.