UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
For appeals against Medical Licensing Committee decisions, the required documentation includes an appeal letter addressed to the Minister of Health and Prevention, along with all documents relevant to the grievance. For appeals relating to previously recorded health advertisement violations, claimants must pro- vide identification documents that substantiate the basis of the appeal. These appeal procedures vary depending on the sec- tor and the regulatory body involved. Each regulatory authority has its own requirements and processes for challenging decisions. It should also be noted that food supplements and cosmetics fall within the scope of the Pharma Law. There is limited publicly available information on chal- lenges to decisions by MOHAP and the EDE, and court cases in the UAE are generally not made public. 1.3 Categories of Pharmaceuticals and Medical Devices Pharmaceuticals are regulated as: • prescription only; • pharmacy only (over-the-counter); • controlled products (includes toxic substances and plants, narcotic and psychotropic substances, and hazardous medical products); • innovative pharmaceutical products; • orphan drugs; • emergency-use medical products; and • compassionate-use products. Medical devices are regulated based on risk, similar to the FDA’s Classes I–III. The medical devices’ classifi- cation determines the permitted sales channels, regu- lating where and how a medical device may be sold.
Devices establish the relevant ethical and regulatory processes. Under the Pharma Law, operating a clinical research entity requires obtaining a licence from the EDE. Among the key requirements for securing an EDE licence are as follows. • Holding a valid GCP Certificate issued by the EDE. • Demonstrating a GCP‑compliant quality manage- ment system and maintaining written standard operating procedures. • Ensuring that all data, including personal data of research participants, remains confidential. The specific “terms, controls, and procedures” gov- erning clinical research will be detailed in the forth- coming Implementing Regulations. Until those regu- lations are issued, the UAE continues to rely on the existing regulatory framework, which is grounded in the GCP standards. Additionally, the DOH and DHA maintain their own clinical research guidelines for studies conducted within their respective emirates, complementing the federal framework. • Department of Health – its guidelines adopt GCP as the core standard, emphasising credible data; the protection of trial subjects’ rights, integrity, and confidentiality; and detailed requirements regarding ethics/research committees, trial authorisation, and safety reporting obligations. • Dubai Health Authority – under the DHA Clinical Tri- als Policy, GCP is also adopted as the fundamental standard, with a focus on safeguarding partici- pants’ rights, safety, welfare, and data confidential- ity. The Dubai Scientific Research Ethics Commit- tee and the DHA Medical Education and Research Department serve as the centralised bodies for approvals and oversight, including mandatory ethical approval, facility authorisation, and adverse event reporting. 2.2 Securing Authorisation to Undertake a Clinical Trial Under the Pharma Law, conducting clinical trials with- out first completing non‑clinical research is prohibited,
2. Clinical Trials 2.1 Regulation of Clinical Trials
Clinical trials of medical products are regulated and overseen by the EDE. Their governance is largely based on the Good Clinical Practice (GCP) frame- work. The federal Guidelines for Conducting Clini- cal Trials with Investigational Products and Medical
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