The Emirates Drug Establishment (EDE) is the single federal authority responsible for Biologics and Biosimilars Regulation in UAE today. Biologics and Biosimilars Registration in UAE is filed through the EDE portal using an eCTD dossier. The whole process now runs through this one body. That’s a recent shift. Under Federal Decree-Law No. 38 of 2024, MOHAP transferred all marketing authorization, GMP certification and pharmacovigilance functions for pharmaceutical and biological products to EDE. This handover took effect 29 December 2025. Guidance still in circulation, a lot of it, references MOHAP as the registering body. All of it is outdated now.
This article covers the regulatory authority, the applicable requirements, the registration process, documentation, clinical and labelling rules, timelines, fees, and post-approval obligations.
Regulatory Authority for Biologics and Biosimilars in UAE
The UAE Biologics Regulatory Authority is EDE, acting under Federal Decree-Law No. 38 of 2024. Marketing authorization, GMP/GDP certification, pharmacovigilance oversight and clinical trial licensing for biologics, biosimilars, vaccines, blood products, plasma-derived medicinal products and ATMPs all fall under this body.
MOHAP’s role today is narrow. It still handles community and compounding pharmacies, along with five narcotics-related services, prescription books, hospital custody authorization, quota determination for private facilities, in-house hospital pharmacy approvals, and day-surgery centre approvals. Biologics registration itself sits with EDE.
Emirate-level bodies add another layer. DoH Abu Dhabi runs its own Drug Authorization system and public drug search tool for the Abu Dhabi market. DHA Dubai maintains its own Dubai Drug Code (DDC) list, updated weekly through its Pharmacy Services department. Both are administered after federal registration. A product needs EDE marketing authorization before it can appear in either emirate’s list.
The clinical trial pathway follows a distinct governance model. A Research Ethics Committee or IRB at the trial site must sign off before enrollment starts, working under the national ethics framework that MOHAP’s National Center for Health Research is now certifying for mutual recognition across sites.
Biologics and Biosimilars Regulatory Requirements in UAE
Biologics Regulatory Requirements UAE and Biosimilars Regulatory Requirements UAE both trace back to one law, Federal Decree-Law No. 38 of 2024, which governs medical products, pharmacists and pharmaceutical establishments. Registration, licensing, advertising and surveillance authority all went to EDE when this law replaced Federal Law No. 8 of 2019. It took effect on 2 January 2025.
Pre-submission requirements for manufacturers:
- Marketing Authorization Holder registration with EDE, completed before any product application
- A UAE-based licensed pharmaceutical establishment, medical warehouse, local manufacturer, or marketing office, to act as applicant
- Current GMP certification for every manufacturing site, issued or recognized by EDE
- Good Distribution Practice compliance across the supply chain
- A pharmacovigilance system in place, since EDE charges a separate fee just to evaluate the pharmacovigilance plan
- Dossier built to eCTD structure, per EDE’s published eCTD Structure guidance
EDE registers biological medicinal products under the same service as conventional pharmaceutical products, rather than running a fully separate biologics track. That’s a distinction worth knowing early, because it shapes how the dossier gets filed.
Biologics and Biosimilars Registration Process in UAE
The Biologics Approval Process in UAE and the Biosimilars Approval Process in UAE both run through EDE’s marketing authorization service for drugs and biopharmaceutical products.
As per EDE’s own published service description, the sequence is:
Step 1: Establishment and MAH registration.
It should be completed with EDE before any product application can be filed.
Step 2: Application submission.
They should be filed through the EDE portal using UAE PASS digital identity login.
Step 3: Document attachment.
The full dossier should be attached in eCTD format.
Step 4: Fee payment.
It covers the application fee and the applicable registration fee.
Step 5: Formal submission.
The application enters EDE’s review queue.
Step 6: Testing and evaluation.
Manufacturer must do stability and bioequivalence testing where required, pharmacovigilance plan evaluation, and pharmaceutical analysis, all run through EDE’s own quality control laboratory.
Step 7: Marketing authorization issuance.
It is valid for five years or for a period EDE determines.
That laboratory step deserves attention. EDE runs its own analysis on submitted samples as part of the process, a step that adds real weight to sample logistics compared with agencies that rely purely on dossier review.
Documents Required for Biologics and Biosimilars Registration
EDE requires the dossier in eCTD format as per its published eCTD Structure guidance document. In line with the ICH M4 Common Technical Document model most reference agencies use, this generally means:
- Module 1: administrative information, application form, product information specific to the UAE submission
- Module 2: quality, non-clinical, and clinical overviews and summaries
- Module 3: manufacturing process, analytical methods and characterization data
- Module 4: non-clinical study reports
- Module 5: clinical study reports and for biosimilars, the comparability package against the reference product
- GMP certificates for all manufacturing sites
- Pharmacovigilance system documentation, since EDE separately charges to evaluate the pharmacovigilance plan
- Certificate of Pharmaceutical Product or Certificate of Free Sale from the country of origin, attested where required
Clinical Trial Requirements for Biologics and Biosimilars
UAE Biologics Clinical Trial Requirements and UAE Biosimilars Clinical Trial Requirements fall under EDE’s authority following the 2025 transition. EDE now issues the Good Clinical Practice Certificate for clinical research entities, a function that previously was under MOHAP.
EDE’s published clinical trial guideline still dates to 2017 and internally references MOHAP’s old regulatory committee by name, so treat it as the working reference but confirm procedural specifics directly with EDE.
Every trial needs:
- Research Ethics Committee / IRB approval at the site level
- Compliance with Good Clinical Practice (GCP)
- Alignment with the national ethics certification scheme MOHAP’s National Center for Health Research is rolling out to enable mutual recognition across institutions and reduce duplicated review for multi-site trials
For biosimilars specifically, the international norm followed across most ICH-aligned agencies and reflected in how comparability packages are typically structured. It centres on
- PK/PD comparability studies against the reference product
- Immunogenicity assessment
- Full clinical efficacy trials only where analytical and PK/PD data leave real uncertainty about biosimilarity
Labelling Requirements for Biologics and Biosimilars
Summary of Product Characteristics, Patient Information Leaflet, outer packaging, Biologics Labelling Requirements UAE treats these as one connected set. Bilingual Arabic and English content is standard across UAE pharmaceutical registration. It is not something to assume away.
Also, Exact label content, batch number placement and barcode format should be confirmed directly with EDE. Packaging artwork shouldn’t be finalized before the SmPC and PIL text is locked with EDE, because any late-stage information change forces a rework.
Timeline for Biologics and Biosimilars Approval
EDE publishes an official service completion time of 45 working days for the marketing authorization of a drug or biopharmaceutical product. This is the target for the core review step.
Total time to market depends heavily on how many review cycles and requests for information the dossier goes through before it is even accepted for review. Treat any estimates beyond the 45-working-day figure as directional only.
Fees for Biologics and Biosimilars Registration
EDE publishes its fee schedule directly on its official marketing authorization service page:
| Fee Component | Amount (AED) |
| Application fee | 100 |
| Marketing authorization for a conventional or biological pharmaceutical product | 7,000 |
| Product analysis or re-analysis | 3,500 |
| Pricing certificate, issued after committee approval | 500 |
| Pharmacovigilance plan evaluation, for the pharmaceutical establishment and its affiliates | 1,000 |
These are the only fees EDE publishes for this specific service. Related categories, such as healthcare products or medical devices, carry separate fee schedules under different EDE services.
Post-Marketing Surveillance Requirements for Biologics and Biosimilars
Pharmacovigilance Requirements for Biologics UAE now falls under EDE, which took over pharmacovigilance oversight as part of the 44 core services transferred from MOHAP on 29 December 2025. This includes:
- Ongoing pharmacovigilance plan compliance, evaluated by EDE for a separate fee at the establishment level
- Manufacturing variations, which require EDE approval before implementation
- GMP inspections, continuing through the product’s lifecycle
- Batch traceability requirements tied to manufacturing site registration
- Product quality complaints and defect reporting, feeding into EDE’s national recall and suspension authority, since EDE holds the power to suspend or recall medical products nationwide
Conclusion
Registering a biologic or biosimilar in the UAE comes down to one federal authority, EDE and an eCTD dossier filed through its portal. That’s a change from what most existing guidance still describes. Manufacturers who confirm current procedures directly with EDE tend to move through the process with far fewer surprises. DoH and DHA formulary access in Abu Dhabi and Dubai remain separate, parallel tracks that start only after EDE marketing authorization is in hand.
For manufacturers navigating the transition from MOHAP to EDE, having the right regulatory partner on the ground makes the difference. Artixio handles dossier preparation, documentation and market entry strategy for the UAE market. Reach out to the experts at info@artixio.com for guidance tailored to your regulatory goals.
FAQs
Q1. Does MOHAP still register biologics and biosimilars in the UAE?
No. EDE, as of 29 December 2025, took over marketing authorization, GMP certification and pharmacovigilance for pharmaceutical and biological products. Community and compounding pharmacies, plus five specific narcotics-related services, still fall under MOHAP’s jurisdiction. Biological Medicinal Products Registration UAE, though, no longer runs through MOHAP as the registering authority.
Q2. Is there a separate approval track for biosimilars in the UAE, distinct from biologics?
Based on EDE’s published service description, biosimilars are registered under the same marketing authorization service as conventional and other biological pharmaceutical products.
Q3. How long does UAE Biologics Marketing Authorization actually take?
EDE publishes 45 working days as the official service completion time for the marketing authorization review. This does not include dossier preparation or correction cycles before submission.
Q4. Does an EDE marketing authorization guarantee my biologic gets used in Abu Dhabi or Dubai hospitals?
No. EDE authorization is the federal prerequisite, but Abu Dhabi’s DoH and Dubai’s DHA each maintain their own drug systems, DoH’s Drug Authorization list and DHA’s Dubai Drug Code, and require separate submissions before a product is funded or claimed within their respective healthcare systems.
Q5. What does EDE’s quality control laboratory step involve during registration?
As per EDE’s service description, the applicant must complete stability and bioequivalence testing where required, along with pharmacovigilance completion and pharmaceutical analysis, through EDE’s own quality control laboratory, before the marketing authorization is issued.
Q6. How long is a UAE biologics marketing authorization valid once granted?
Five years or for a period EDE determines as per its published service terms.
