The UAE has reorganised the way it regulates medical products. A new federal authority, the Emirates Drug Establishment (EDE), is now taking over the registration services that foreign manufacturers once handled through the Ministry of Health and Prevention. This briefing explains what is moving, what is staying the same, and what it means for your file.
A new federal authority for medical products
Federal Decree-Law No. 38 of 2024 established the Emirates Drug Establishment (EDE) as the UAE federal authority for medical products. The law came into force on 2 January 2025, and it gives the EDE responsibility for the regulatory functions that surround a medicine or a medical device across its life on the market.
Through late 2025 and into 2026, the EDE has been assuming the core registration services that were previously run by the Ministry of Health and Prevention (MOHAP). Submissions are moving to the EDE platform at ede.gov.ae. For a foreign manufacturer, the headline is consolidation: one federal authority now sits at the centre of the process, rather than the previous ministry-led arrangement.
What actually changes
The transition is best understood as a change to who runs the process and how submissions are made, rather than a rewrite of the underlying technical standards. Three things stand out.
What is moving under the EDE
- A single federal authority for medical products, instead of registration sitting with the ministry
- Centralised and increasingly online submissions through the EDE platform at ede.gov.ae
- EDE oversight of services such as product registration, classification, pricing, and pharmacovigilance
Because these services now sit under one roof, a manufacturer dealing with registration, classification, pricing, and pharmacovigilance is increasingly dealing with one authority and one platform rather than several touchpoints. Over time this should make the path more predictable, but during the changeover it pays to confirm exactly where each step now lives.
What stays the same
Just as important is what has not changed. The EDE has not removed the structural rules that foreign manufacturers have always had to plan around.
Your UAE local representative
Foreign manufacturers register through a UAE-licensed local representative, who also acts as the Marketing Authorisation Holder. This entity submits the application and carries the ongoing regulatory responsibility for your product in the UAE, so you do not need your own UAE company. It acts on your behalf, you keep ownership of the registration, and it can be moved to another representative at any time. The arrival of the EDE does not change this requirement: it remains the first practical step for any international company entering the market.
Dossiers remain rigorous
The technical bar has not dropped. Dossiers remain rigorous, and the data supporting a product's quality, safety, and efficacy is still expected in full. A well-prepared file is still the single biggest factor in how smoothly an application moves.
Bilingual labelling is still required
Bilingual English and Arabic labelling is still required. Artwork and leaflets that meet this standard remain part of the submission, so this is not an area where the transition offers any relief.
Navigating the transition in practice
The most important practical point during the changeover is routing. Some pathways may still reference MOHAP while newer submissions go through the EDE, so manufacturers should confirm the current submission route before starting a file. Beginning a dossier against the wrong channel is an avoidable way to lose time.
For most foreign manufacturers, the simplest way to stay aligned is to work through a local regulatory partner who is already operating on the EDE platform day to day. A partner that acts as your local representative can confirm the live route, prepare the dossier to the current standard, and manage the submission so that the transition does not become your problem.
Frequently asked questions
What is the Emirates Drug Establishment (EDE)?
What changes for foreign manufacturers under the EDE?
Can a foreign manufacturer register a product directly with the EDE?
Do submissions now go to the EDE or to MOHAP?
Has the EDE relaxed dossier or labelling requirements?
This briefing is general information, not regulatory or legal advice. UAE requirements are actively changing during the MOHAP to EDE transition; confirm current rules with the relevant authority or your regulatory partner before acting.