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 EU pathways
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: the Department of Health Abu Dhabi (DoH) maintains its own approved drug formulary, and the Dubai Health Authority (DHA) oversees facility and distribution licensing in Dubai, so market access often means both a federal registration and separate emirate-level steps. Dossiers follow the CTD and eCTD structure with bilingual Arabic and English labelling, and a foreign manufacturer must appoint a locally licensed agent or distributor. The EDE offers a shorter verification route for products already approved by reference authorities such as the EMA, FDA, and MHRA. Registration is valid for five years, pharmacovigilance is centralized under the EDE with a resident qualified person, and traceability runs through the national Tatmeen system. The UAE also participates in the GCC centralised registration pathway.
- What we prepare
- CTD and eCTD dossiers for EDE federal registration
- Verification-pathway submission packages for reference-approved products
- Regulatory strategy: federal and emirate-level planning, and GCC route assessment
- Bilingual Arabic and English labelling content and artwork text
- DoH Abu Dhabi formulary and emirate-level guidance
- Responses to EDE requests for information, and 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
Who registers drugs in the UAE now, MOHAP or EDE?
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.
Do I need both federal and emirate approvals?
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.
Do we need a local agent in the UAE?
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.