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2 min read
Introduction
The United Arab Emirates (UAE) has emerged as one of the fastest-growing pharmaceutical markets in the Middle East. With the establishment of the Emirates Drug Establishment (EDE) as the national Regulatory authority overseeing medicinal product registration, licensing, and pharmacovigilance, understanding the Regulatory landscape has become crucial for manufacturers and Regulatory professionals seeking market entry.
This guide provides a step-by-step overview of the medicinal product registration process in the UAE, helping Regulatory professionals streamline submissions and ensure compliance with EDE’s evolving requirements.
1. Regulatory Architecture & Pathways under EDE
The Emirates Drug Establishment (EDE) regulates the entire lifecycle of medicinal products in the UAE from clinical trial authorization to post-market surveillance.
Key Regulatory aspects include:
- Marketing Authorization (MA) & Product Registration: All pharmaceutical products must be registered with EDE before being marketed or imported into the UAE.
- Dossier Submission (CTD/eCTD): EDE requires submission in Common Technical Document (CTD) or electronic CTD (eCTD) format, ensuring alignment with international ICH standards.
- Pharmacovigilance (PV) Requirements: Companies must establish a local PV system, appoint a Qualified Person for Pharmacovigilance (QPPV), and ensure timely reporting of adverse drug reactions.
- MAH & Manufacturing Site Registration: Manufacturing sites must hold valid GMP certificates issued or recognized by EDE.
2. Step-by-Step Guide: How to Register a Medicinal Product in the UAE
Step 1 – Pre-Submission Planning
- Determine the product classification (new chemical entity, generic, biologic, vaccine, etc.).
- Appoint a local Marketing Authorization Holder (MAH) or authorized local agent registered with EDE.
- Verify that manufacturing and import facilities comply with EDE licensing standards.
Step 2 – Dossier Preparation (CTD/eCTD)
- Module 1: UAE-specific administrative and legal information, GMP certificates, Free Sale Certificate (FSC), CPP, and labeling templates.
- Modules 2–5: Quality (CMC), non-clinical, and clinical documentation aligned with EDE guidelines and ICH requirements.
- Ensure the dossier is bilingual (Arabic and English) and formatted for eCTD submission.
Step 3 – Submission & Review Process
- Submit the dossier through the EDE digital portal along with applicable review fees.
- Monitor the application status and respond promptly to EDE queries.
- Follow up for the Product Stability approval, Pricing approval
- Submitting the Samples for Lab Analysis with its related Reference standards and columns.
- Final Certificate approval
Step 4 – Post-Approval Compliance & Lifecycle Management
- Maintain valid marketing authorization through timely renewals and variation of submissions.
- Establish a pharmacovigilance system and submit Periodic Safety Update Reports (PSURs) as required.
- Ensure labeling, promotional materials, and advertising meet EDE regulations (Arabic/English compliance, no misleading claims).and should be approved from EDE before distributing to the market.
3. Key Challenges for Regulatory Affairs Professionals in the UAE
- Adapting to evolving EDE frameworks: The Emirates Drug Establishment continues to refine and digitize its registration systems.
- Transition to eCTD submissions: Companies must invest in compliant eCTD platforms and data integrity validation.
- Arabic labeling and localization: Ensuring accurate bilingual labeling remains a top compliance challenge.
- Regulatory harmonization: Aligning EDE requirements with GCC and ICH standards for faster approval.
- Emerging Trends in UAE Regulatory Affairs
- Full digital transformation of drug registration and lifecycle management through EDE’s online portal.
- Increased focus on innovative drugs, biologics, and rare disease therapies.
- Greater reliance on real-world evidence (RWE) and pharmacovigilance data to support post-approval decisions.
- UAE’s growing position as a regional pharmaceutical hub for MENA, offering expedited market access pathways.
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