The UAE has consolidated pharmaceutical regulation under one federal body. According to the Emirates Drug Establishment (EDE), it was established on 29 September 2023 and is the federal authority responsible for regulating medical and pharmaceutical products, including medical devices, blood derivatives, stem cells, medicated cosmetics and veterinary medicines. This regulatory roadmap for manufacturers covers pharmaceutical product registration in the UAE, also called drug registration: who should register as a Marketing Authorisation Holder, how EDE services and UAE PASS are accessed, marketing authorisation validity and post-approval pharmacovigilance obligations.
Discover the HERMS life sciences platform and our regulatory affairs expertise.
Who registers pharmaceutical products in the UAE?
EDE is the single federal regulator. Marketing authorisations, establishment licensing and pharmacovigilance services sit with EDE, taking over functions previously handled by the Ministry of Health and Prevention (MOHAP). The legal basis is Federal Decree-Law No. 38 of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments, in force since 2 January 2025, which replaced Federal Law No. 8 of 2019.
How are EDE services accessed?
EDE services are digital-first and accessed online. UAE PASS is used for authentication on several services.
How long is a marketing authorisation valid?
EDE's service page states that marketing authorisation certificates (the product registration certificate) are issued for five years or for the validity it grants.
Is a pharmacovigilance officer required?
Marketing Authorisation Holders apply to EDE to approve and register their Qualified Person for Pharmacovigilance (QPPV).
For further reading, explore HERMS’s overview of adverse-event reporting and ICSR processing. For official reporting, use the applicable authority channel, such as EDE’s reporting service for pharmaceutical facilities or the Saudi Vigilance System.
What are the requirements for drug registration in the UAE?
According to EDE’s marketing authorisation service page, the service allows customers to submit applications to register conventional, biological or other human pharmaceutical products to be imported and traded within the UAE. The process starts with a UAE PASS login, then the application form, the required documents and payment of the fees.
- Marketing Authorisation Holder (MAH): MAH companies must be registered by EDE before they can apply for marketing authorisation of their products.
- Applicant: the applicant must be a medical warehouse licensed by EDE with a valid licence, a local medical product manufacturer, or a marketing office.
- Documents: documents are submitted in accordance with the standard technical file (eCTD).
How long does drug registration take in the UAE, and what does it cost?
EDE lists a service completion duration of 45 working days. Its published fees are an application fee of AED 100, AED 7,000 for marketing authorisation of a conventional pharmaceutical product, AED 3,500 for analysis or re-analysis of a medical product, AED 500 for the pricing certificate after committee approval and AED 1,000 for pharmacovigilance (PV) plan evaluation. Confirm the current figures on EDE’s service page before planning a submission.
What companies should do now
- Confirm that company, manufacturer and product records are correctly reflected under EDE.
- Review renewal dates and variation plans against current EDE procedures.
- Verify the status of your local QPPV and pharmacovigilance system documentation.
- Monitor EDE legislation and guideline updates, which are published on its portal.
How HERMS supports
HERMS acts as a regulatory partner for companies entering or operating in the UAE, supporting UAE market entry, market access and product registration: company and manufacturer registration, registration dossier preparation, submission management, registration maintenance through renewals and variations, regulatory monitoring of EDE updates, and pharmacovigilance support. Contact HERMS.
HERMS provides consultancy and advisory support to pharmaceutical and healthcare companies across regulatory affairs, market access and commercial development. We help businesses assess opportunities, navigate requirements and make informed decisions.
HERMS supports registration dossier preparation and pharmacovigilance activities for pharmaceutical and healthcare companies. Our services help businesses prepare regulatory documentation and address product safety requirements.
Distributor search and partner selection
HERMS helps pharmaceutical and healthcare companies identify suitable distributors and evaluate local partners for UAE and GCC market entry. Our support covers partner search, capability assessment and selection aligned with your regulatory and commercial objectives. Contact HERMS.
Registration assessment software
RULEXIS, SYNCRA and REGAXIS are HERMS software products dedicated to registration assessment. Explore HERMS solutions.
Regulatory information management, eCTD dossiers and change monitoring
Successful UAE and GCC registration depends on disciplined regulatory information management: controlled product and registration data, dossier preparation in eCTD and CTD structure, submission tracking, lifecycle and variation management, and continuous regulatory change monitoring against Emirates Drug Establishment and SFDA requirements. Companies comparing regulatory intelligence, submissions and lifecycle tools should assess GCC requirement coverage, evidence traceability, controlled human review and integration with existing regulatory and quality systems.
Pharmacovigilance case intake, signal detection and safety reporting
Marketing authorisation holders also need a working pharmacovigilance process: adverse event intake, ICSR case processing, regulatory safety reporting, literature monitoring and signal detection. See our guidance on pharmacovigilance obligations in the GCC and ICSR processing challenges.
Market access, pricing and tender intelligence
Registration is the first step to commercial launch. Pricing and market-access planning, launch sequencing, evidence review and tender intelligence for GCC public procurement should be considered alongside the registration timeline.
Related reading
- The Emirates Drug Establishment: What Changes for Pharmaceutical Companies in the UAE
- HERMS regulatory affairs
- Pharmacovigilance in the GCC: Obligations Every Marketing Authorisation Holder Must Meet
- Medical Device Registration in UAE
- Medical Device Registration in the GCC: Planning a Country-Specific Market Entry Strategy
- Medical Device Labelling in the UAE and KSA: What Manufacturers Should Prepare
- Outsourcing Regulatory Compliance Solutions