The UAE's Federal Law No. 38 of 2024, effective January 2, 2025, supersedes Federal Law No. 8 of 2019, establishing a contemporary regulatory framework for medical products, the pharmacy profession, and pharmaceutical establishments.

The legislation designates the Emirates Drug Establishment (EDE) as the primary regulatory authority, centralising duties related to product approvals, pharmacovigilance, and market monitoring. It expands the range of regulated commodities to encompass new therapies, orphan pharmaceuticals, nutritional supplements, genetically modified organisms, cosmetics, chemical precursors, and controlled substances. Furthermore, it oversees compounding pharmacies, biobanks, and clinical research organisations.

Fundamental provisions encompass conditional approvals for life-threatening diseases, emergency use authorisations, expedited procedures, and compassionate use rules to enhance access to vital therapies. The EDE will establish the UAE Pharmacopoeia to define national standards for safety, efficacy, and quality in accordance with international best practices. Augmented intellectual property rights safeguard data and promote innovation, with the objective of attracting foreign investment and enhancing pharmaceutical progress. Enhanced pharmacovigilance, product tracking databases, and recall systems improve post-market safety.

Federal Law No. 38 of 2024 establishes the UAE as an international centre for medicines, guaranteeing product safety, enhancing public health results, and cultivating a competitive investment climate. The act enforces more severe penalties for non-compliance, establishes elevated licensing criteria for pharmaceutical experts and establishments, and amplifies healthcare facilities' obligations for secure storage and delivery.

Manufacturers and distributors must conform to revised approval protocols and pharmacovigilance criteria. Healthcare establishments encounter rigorous storage and distribution mandates, while chemists are required to fulfil heightened license standards. Enhanced intellectual property protections and innovation incentives bolster the UAE's objective of becoming as a leader in the pharmaceutical and medical products industries.