1. Executive Summary

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 pharmaceutical industries in the UAE are regulated at both federal and Emirate levels. 

The UAE government has extensive powers of discretion and may impose fines or criminal sanctions for the breach of healthcare regulations. It is the intention of the UAE to position itself as a global player in the manufacture and provision of medication and healthcare and achieve the Strategic Objectives and Program of the Dubai Health Authority via the Dubai Health Strategy. This includes the implementation of leading technology and a focus on research and development to attract qualified medical professionals and researchers.

The regulations which have been developed by two of the Emirates, Dubai and Abu Dhabi, are the most advanced in the UAE and set the standard which is followed by the remaining five Emirates. In the Emirate of Dubai, the Dubai Health Authority serves a dual role as regulator and operator of the healthcare sector. There are two healthcare “free zones” in Dubai, which enable the establishment of 100% foreign-owned businesses which benefit from tax and duty exemptions. These are Dubai Healthcare City* (dedicated to providing high-quality healthcare via two hospitals and approximately 120 outpatient medical centers and diagnostic laboratories with approximately 4,000 licensed professionals) and Dubai Biotechnology and Research Park (dedicated to life sciences).

*Dubai Healthcare City Authority (DHCA) operates as an independent regulator of Dubai Healthcare City Free Zone. This guidebook will not cover the clinical trial requirements conducted under the DHCA.

This guidebook focuses on the procedure to be followed for new clinical trial applications with medicinal investigational products in Dubai and will explore the acceptability of decentralized elements in clinical trials.