UAE enacts new pharma law to become global hub for innovation

DUBAI: The United Arab Emirates (UAE) has taken a transformative step toward reshaping its health sector with the enactment of a Federal Decree-Law regulating medical products, pharmacy practices, and pharmaceutical institutions. This landmark legislation, introduced by the UAE Government, is designed to align the nation’s pharmaceutical sector with global standards, ensuring safety, efficiency, and innovation across all facets of the industry.
The law establishes comprehensive oversight for a wide array of medical and health-related products, including medicines, medical devices, biological products, dietary supplements, cosmetics, and genetically modified products. Additionally, it regulates controlled substances and hazardous materials for human and veterinary use. Pharmaceutical establishments, ranging from pharmacies to medical warehouses, manufacturing facilities, research institutions, and biobanks – including those in free zones – must adhere to the new regulations.
Key objectives of the decree include enhancing organization, security, and compliance in the pharmaceutical sector, streamlining approval processes, and strengthening supervision across development stages. The legislation aims to position the UAE as a global hub for pharmaceutical innovation, fostering growth while maintaining high standards of safety and competitiveness.
Pharmacy practitioners are now required to register with the Ministry of Health and Prevention or other relevant local authorities. The law also sets strict guidelines for licensing and monitoring, ensuring accountability in the pharmacy profession. The Emirates Drug Establishment, in collaboration with the Ministry of Health and local health authorities, will oversee licensing, monitoring, and compliance, including ownership transfers, temporary suspensions, precautionary closures, and license revocations.
The law introduces an incentive framework to attract investments and drive innovation, with a particular focus on safeguarding data and documents related to new medical products. To ensure compliance, it imposes penalties for violations, including fines ranging from AED 1,000 to AED 1 million for institutions and up to AED 500,000 for pharmacy practitioners. Severe infractions may result in license suspension or revocation.
This progressive regulatory move underscores the UAE’s commitment to advancing its health sector, ensuring a safe, well-regulated environment for professionals and consumers alike. By fostering investment, innovation, and growth, the UAE solidifies its position as a leader in the global pharmaceutical industry.