United Arab Emirates
Ministry of Health and Prevention (MoHAP)
Verified 12 September 2026 by Wilson Blaney, ACQI, RP (GDP) trained
5 days agoMarketing authorisation fees were re checked against the regulator. The priced pathways below are confirmed against the schedule named in each note. Where a pathway shows no amount, the regulator publishes no single figure for it or the figure could not be confirmed, and this is stated in the note rather than estimated.
3 of 4 pathways carry a confirmed fee
Contributor Wilson Blaney, ACQI, RP (GDP) trained
The United Arab Emirates regulates pharmaceuticals through a federal to 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.
About the authority
MoHAP's Drug Department handles federal pharmaceutical registration, importation, pricing, and pharmacovigilance. Within the federal structure, the Department of Health Abu Dhabi (DoH) and Dubai Health Authority (DHA) act as parallel emirate-level regulators for facility licensing, insurance formularies, and intra-emirate distribution. The Tatmeen platform (operated by Evoteq under MoHAP contract) handles serialisation/track-and-trace.
International affiliations
Reliance & recognition
MoHAP operates a strong reliance framework: (a) SRA reliance for accelerated review; (b) GCC Centralised Procedure for regional approval; (c) GMP reliance for SRA-inspected sites. Reliance is the dominant route for innovative medicines.
Compare United Arab Emirates side-by-side
Benchmark timelines, fees and pathway requirements against another market.
Other Middle East & Africa markets
Same structure. Same source-citation standard.