UAE
UAE
Medwisdom Lifescience offers comprehensive, MOHAP-compliant Regulatory Affairs services for the UAE — covering pharmaceuticals, biologics, medical devices, cosmetics, and nutraceuticals with expert dossier preparation, electronic submissions, local agent coordination, and full lifecycle management under the new Federal Decree-Law No. 38 of 2024.
Overview
The Ministry of Health and Prevention (MOHAP) is the federal regulatory authority for all health products in the UAE. Since 2023, the Emirates Drug Establishment (EDE) operates under MOHAP to strengthen oversight. The UAE follows ICH guidelines, accepts eCTD submissions, and offers accelerated reliance pathways for products approved by stringent authorities (FDA, EMA, etc.).
From January 2025, Federal Decree-Law No. 38 of 2024 fully governs drugs, devices, and cosmetics with enhanced digital processes and stricter post-market requirements.
Registration Process for Drugs and Medical Devices
All submissions are 100% electronic via MOHAP’s portal.
- Pharmaceuticals & Biologics
1. Appoint UAE-licensed local agent/pharmacy. 2. Submit eCTD dossier. 3. Pricing application (if applicable). 4. Technical & pricing committee review. 5. Issuance of registration certificate valid for 5 years. - Medical Devices & IVDs
1. Risk classification (I–IV). 2. Submit technical file (GHTF/STED format). 3. Clinical/performance evaluation. 4. UDI compliance. 5. Registration valid for 5 years with annual listing.
Tentative Registration Timelines (2025)
| Product Type | Timeline |
|---|---|
| New Drugs / Biologics (Full Review) | 12–18 months |
| Generics / Biosimilars (Reliance Pathway | 6–10 months |
| Fast-Track (FDA/EMA approved) | 3–6 months |
| Medical Devices (Low Risk) | 2–4 months |
| Medical Devices (High Risk) | 6–12 months |
| Cosmetics Notification | 1– 30 days |
| Renewals / Variations | 2–6 months |
Challenges in UAE Regulatory Affairs
While the UAE is one of the fastest markets in the region, applicants often face:
- Mandatory bilingual (Arabic + English) labeling and IFUs
- Strict pricing approval required before registration finalisation
- Need for UAE-licensed local agent/pharmacy for all submissions
- Frequent updates to eCTD validation rules causing rejections
- Transition to Federal Decree-Law No. 38/2024 requirements in 2025
- UDI and traceability implementation for devices
Medwisdom eliminates these hurdles with our UAE-licensed team, perfect Arabic translations, and 100% first-time-right submission record.
Our Regulatory Affairs Services for UAE
- Local Agent / Pharmacy Services
MOHAP-licensed partner for submissions - eCTD Dossier Compilation & Submission
Modules 1–5 with UAE-specific Module 1 - Arabic Labeling & Artwork
Native translation, mock-ups, readability - Pricing Applications
Full pricing dossier & committee support
- Medical Device Technical Files
GHTF/STED, UDI, clinical evaluation - Cosmetics & Supplements Notification
Ingredient safety, labeling compliance - Variations, Renewals, Lifecycle
All Type IA/IB/II changes - Regulatory Intelligence & 2025 Law Updates
Why Choose Medwisdom for UAE Regulatory Affairs
- UAE-licensed local agent & pharmacy — no third-party dependency
- Native Arabic medical translators for flawless labeling
- 15+ years of MOHAP submission experience with zero rejections in 2024–2025
- Expertise in fast-track & reliance pathways (FDA/EMA)
- Full pricing committee support — critical for final approval
- Comprehensive device & non-drug product coverage
- Real-time regulatory intelligence on 2025 law changes
- Transparent project tracking and weekly client updates
Key Official Regulatory Resources – UAE
- MOHAP Drug Registration Portal
Electronic submissions, guidelines, circulars
mohap.gov.ae – Drug Registration - MOHAP Medical Devices Section
Device classification, technical file requirements
Medical Devices Registration - UAE eCTD Validation Criteria & Guidelines
Mandatory format specifications
eCTD Guidance PDF