UAE Drug Registration Support (EDE)
The UAE has restructured its drug regulation. Under Federal Decree-Law No. 38 of 2024, the new Emirates Drug Establishment (EDE) has taken over federal registration of medicines and medical devices from the Ministry of Health and Prevention (MOHAP), consolidating oversight under a single specialized authority. EvySaif provides UAE drug registration support, preparing the dossiers and regulatory strategy for this new landscape, so your submission reflects the current framework, not the old one.
Understanding the UAE pathway
Pharmaceutical and device registration in the UAE is now federal, handled by the EDE, with MOHAP retaining community and compounding pharmacies and certain narcotic controls. Above that federal layer, emirate authorities run their own systems, so market access often means both a federal registration and separate emirate-level steps.
Register federally with the EDE
Dossiers follow the CTD and eCTD structure with bilingual Arabic and English labelling. The EDE offers a shorter verification route for products already approved by reference authorities such as the EMA, FDA, and MHRA.
Plan the emirate layer
The Department of Health Abu Dhabi maintains its own approved drug formulary, and the Dubai Health Authority oversees facility and distribution licensing in Dubai, so distribution and formulary inclusion can involve separate emirate-level steps.
Set up the local obligations
A foreign manufacturer must appoint a locally licensed agent or distributor to file. Pharmacovigilance is centralized under the EDE with a resident qualified person, and traceability runs through the national Tatmeen system.
Register, then extend
Registration is valid for five years, and the UAE also participates in the GCC centralised registration pathway, which can extend recognition across the six GCC states.
Framework watch: the shift from MOHAP to the EDE has left many submissions being prepared against an outdated framework. Every dossier we build reflects the current EDE structure, not the old one.
What we prepare
EDE eCTD dossiersCTD and eCTD dossiers for federal registration.
Verification packagesSubmission packages for reference-approved products.
Regulatory strategyFederal and emirate-level planning, and GCC route assessment.
Bilingual labellingArabic and English labelling content and artwork text.
Emirate guidanceDoH Abu Dhabi formulary and emirate-level guidance.
Query responses and PVResponses to EDE requests for information, plus pharmacovigilance documentation.
How EvySaif helps
We are your dossier writing and strategy partner for the UAE. We build the eCTD submission for the EDE, map the federal and emirate-level steps you will face in Abu Dhabi and Dubai, and advise on the verification route and GCC option. Because the framework requires a locally licensed agent to file, we work alongside yours, so your submission reflects the current EDE structure and is correctly routed.
Why EvySaif
EvySaif stands among the best research and medical writing consultancies in India, and the UAE is a core market in our regional focus. The recent shift from MOHAP to the EDE has left many submissions being prepared against an outdated framework, and our current, accurate grasp of the new structure is exactly what a clean submission now needs.
Frequently asked questions
Following the 2025 transition, now essentially complete, the Emirates Drug Establishment (EDE) is the federal authority for drug and device registration. MOHAP retains community and compounding pharmacies and certain narcotic controls.
Often, yes. Federal registration is through the EDE, while distribution and formulary inclusion in Abu Dhabi (DoH) or Dubai (DHA) can involve separate emirate-level steps.
Yes. A foreign manufacturer must appoint a locally licensed agent or distributor to file. We prepare the dossier and strategy and work alongside that agent.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
Request a proposalRegulatory submissions in other markets
Entering the UAE market?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
Request a proposal