United Arab Emirates

Executive summary

The United Arab Emirates regulates pharmaceuticals through a federal–emirate dual structure. The Ministry of Health and Prevention (MoHAP) handles federal product registration (essential for marketing anywhere in the UAE), while two emirate-level health authorities — the Department of Health Abu Dhabi (DoH) and the Dubai Health Authority (DHA) — license facilities, regulate insurance formularies, and enforce pricing/distribution within their respective emirates. MoHAP's Drug Department was restructured in 2017 and operates the integrated REQTI electronic submission portal. The UAE accepts ICH-CTD/eCTD, recognises SRA approvals (FDA, EMA, MHRA, TGA, Health Canada, Swissmedic, PMDA) for reliance, and is part of the GCC Centralised Procedure. The Tatmeen national track-and-trace platform (live since 2021, full enforcement 2025) is one of the most advanced GS1-based serialisation systems globally and is now mandatory for all pharmaceutical products at primary, secondary, and tertiary pack levels. The UAE is a strategic regional hub for pharma (Dubai is GCC's largest re-export centre via Jebel Ali Free Zone). Vision 2031 and the National Strategy for Advanced Sciences are driving investment in clinical trials, biotech manufacturing, and AI-assisted regulatory review. Insurance reimbursement is fragmented across DHA (Dubai), DoH (Abu Dhabi via Daman/Thiqa), and private insurers; HTA is emerging but not yet mandatory.