Dubai (UAE)

DCT Feasibility Assessment Dubai (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. Disclaime...

Dubai 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 biotechnology and ...

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 Ethic...

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 Dubai Scientific Research Ethics Committee (DSREC) acts as the Central Ethics Committee fo...

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 c...

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...

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.)? Dubai Health Authority has not yet issued specific guidance on conducting clinical tri...

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 is clear that there are no regulations that d...

10.1 Clinical Trial with Investigational Medicinal Product See the Regulatory Process for Interventional Clinical Trial approved by the MOHAP and Ethics Committee (see page 25 of the “ Guidelines for Conducting Clinical Trials with Investigationa...

UAE laws and legislation (not all are available in English) may be accessed via the UAE Ministry of Justice website or via the UAE Legislation website . Ministry of Health and Prevention https://mohap.gov.ae/   Dubai Health Authority ...

None.