1. Home
  2. legal updates
  3. new era pharmaceutical regulation uae key changes under federal law no 38 2024 uae

The New Era of Pharmaceutical Regulation in the UAE: Key Changes Under Federal Law No. 38 of 2024 (UAE)

Release Date

The UAE has introduced Federal Law No. 38 of 2024, replacing Federal Law No. 8 of 2019 concerning medical products, pharmacists, and pharmaceutical establishments. The new legislation came into force on the 2nd of January, 2025 and implements significant reforms to the regulation of medical products and pharmaceutical practices, with a focus on enhanced safety, stricter compliance, and modernised regulatory frameworks.

Key Provisions:

  1. Introduction of the Emirates Drug Establishment (EDE): The EDE is now the central authority overseeing medical product approvals, pharmacovigilance, and market monitoring, consolidating regulatory authority previously spread across multiple entities.
  2. Expanded Product Definitions: The law provides clearer classifications, including advanced medical treatment products, orphan pharmaceutical products, and food supplements, broadening the scope of regulated items.
  3. Marketing Approval System: The EDE grants marketing authorisationsbased on enhanced quality and safety standards, including conditional approvals for life-threatening conditions and emergency use authorizations.
  4. Compassionate Use and Fast-Track Approvals: Provisions for compassionate use and fast-track marketing approvals have been introduced to expedite access to innovative treatments and critical medicines.
  5. Intellectual Property Protection: Strengthened protections for innovative medical products, including defined regulatory data protection periods.
  6. Pharmacovigilance and Recall Mechanisms: Stricter requirements for post-market surveillance, adverse event reporting, and product recalls have been mandated.
  7. Increased Penalties for Non-Compliance: The law introduces stronger enforcement measures, including penalties for non-compliance with marketing standards, product quality requirements, and unauthorized sales.

Implications for Stakeholders:

  • Manufacturers and Distributors: Must adapt to the new marketing approval processes and ensure adherence to pharmacovigilance requirements under EDE oversight.
  • Healthcare Facilities: Enhanced compliance obligations in dispensing and storage of pharmaceuticals.
  • Pharmaceutical Professionals: Stricter licensing and competency requirements for pharmacists and clinical pharmacists.
  • Investors and Innovators: Strengthened protections for intellectual property encourage pharmaceutical innovation and foreign investment in the UAE market.

 

Comparative Analysis: Federal Law No. 8 of 2019 vs. Federal Law No. 38 of 2024
ProvisionFederal Law No. 8 of 2019Federal Law No. 38 of 2024Key Changes/Implications
Regulatory AuthorityMinistry of Health and Prevention (MOHAP)Emirates Drug Establishment (EDE)EDE centralizes regulatory authority, creating a more cohesive enforcement structure.
Product DefinitionsMedical and pharmaceutical products onlyExpanded to include biopharmaceuticals, food supplements, cosmeticsBroader regulatory scope for enhanced consumer safety and market clarity.
Marketing ApprovalsIssued by MOHAP based on compliance evidenceEDE issues approvals with stricter compliance, including conditional and fast-track options.More flexible pathways for innovative treatments.
PharmacovigilanceBasic requirements for reporting adverse eventsEnhanced with mandatory reporting timelines and expanded definitions.Stricter obligations for reporting adverse reactions and quality concerns.
Product Recall MechanismsManaged by MOHAP with basic provisionsEDE implements detailed recall protocols and compliance deadlines.Increased clarity and efficiency in recall procedures.
Intellectual Property ProtectionGeneral references to IP rightsClear IPprotection periods and enforcement measuresStronger incentives for pharmaceutical innovation and IP protection.
Penalties for Non-ComplianceFines and product suspensionsHigher fines, suspensions, and market bans for violationsStricter enforcement aimed at ensuring regulatory compliance.

 

Conclusion:
Federal Law No. 38 of 2024 introduces a modernised regulatory landscape for the UAE’s pharmaceutical sector, enhancing consumer protection, regulatory efficiency, and innovation incentives. Stakeholders should review internal compliance policies to align with the new provisions and engage proactively with the EDE to ensure continued market access and regulatory adherence.

Key Contacts

Andrea Tithecott, Partner, Head of Regulatory and Healthcare (A.Tithecott@tamimi.com)

Christina Sochacki, Senior Counsel (C.Sochacki@tamimi.com)

Country
United Arab Emirates