UAE: New Era for Pharmaceutical Regulations
03-Jan-2025 ABU DHABI - The UAE has introduced Federal Law No. 38 of 2024, replacing Federal Law No. 8 of 2019 concerning medical products, pharmacies, and pharmaceutical businesses, with the aim of enhancing organization, security, and efficient oversight of development and distribution processes.
The new legislation came into force on January 2, 2025, bringing significant changes. Some of the key changes are highlighted below:
1. Intellectual Property Protection: The new law provides strengthened protections for innovative medical products, including defined regulatory data protection periods. This means that documents and data related to innovative products and medical products with at least one new active ingredient (which can either be developed in the UAE or imported) will now be subject to regulatory protection.
2. Introduction of the Emirates Drug Establishment (EDE): The EDE is now the central authority responsible for overseeing medical product approvals, pharmacovigilance, and market monitoring. This consolidates the regulatory authority that was previously spread across multiple entities.
3. Encouraging Investors and Innovators: The new law also aims to encourage pharmaceutical innovation and foreign investment in the UAE market by providing stronger protections for intellectual property.
In conclusion, the UAE's new law marks a new era for pharmaceutical regulations in the country and is expected to bring numerous benefits for both the industry and consumers.