UAE Unveils Sweeping New Pharmaceutical and Medical Products Law
Abu Dhabi, UAE – The United Arab Emirates has introduced Federal Decree-Law No. 38/2024, a landmark piece of legislation governing medical products, the pharmacy profession, and pharmaceutical establishments. This new decree-law, which repeals previous regulations from 2019, aims to solidify the UAE’s position as a leading global hub for the pharmaceutical and medical industries. The comprehensive law is set to significantly impact a broad spectrum of medical stakeholders, from research entities and manufacturers to pharmacies and marketing companies.
A central feature of the new framework is the establishment of the Emirates Drug Establishment (EDE). This new federal authority will assume the critical role previously held by the Ministry of Health and Prevention, becoming the primary body responsible for issuing medical product approvals, including marketing authorisations (MAs), import/export permits, licensing, and advertising approvals. The EDE will also oversee good practice certifications, pharmacovigilance monitoring, and possess the authority to suspend or withdraw medical products.
The scope of regulated products and establishments under the new law has been significantly expanded. Definitions for terms such as ‘medical product,’ ‘pharmaceutical product,’ and ‘biopharmaceutical products’ have been clarified and broadened to include biopharmaceuticals, food supplements, cosmetic products, and genetically modified organisms intended for medical use, alongside traditional medicines, medical devices, and pharmaceuticals. Similarly, the law now explicitly covers a wider range of establishments, including research and development entities, laboratories, manufacturers, marketing offices, and notably, biobanks, which were not explicitly addressed in prior legislation.
The process for obtaining marketing authorisations has been made more stringent, requiring extensive clinical evaluations, safety and efficacy assessments, and robust pharmacovigilance systems. MAs will typically be valid for five years and are renewable. The law introduces several new categories of MAs to address diverse needs:
- Exclusive MAs: Granted to a single entity for marketing specific products to specific entities in the UAE.
- Conditional MAs: Available for orphan drugs, treatments for rare diseases, or products unavailable in the UAE, contingent on an existing MA in a recognized reference country and a commitment to apply for a regular MA. These are valid for up to one year.
- Emergency Use MAs: Facilitate rapid deployment of medical products during public health emergencies, remaining valid for the duration of the emergency.
- Fast-track MAs: Simplified procedures for innovative medical products of therapeutic importance, with specifics to be detailed in future executive regulations.
A significant development for the commercial and intellectual property landscape is the introduction of specific regulatory protections for documents and data related to innovative medical products and those containing new active ingredients. This provision aims to incentivize the launch of innovative products within the UAE market, although the exact period, mechanism, and system for this protection are awaiting clarification in the upcoming executive regulations.
Further strengthening product safety, the new law mandates enhanced pharmacovigilance standards, introducing stricter monitoring, adverse event reporting requirements, and mandatory reporting timelines. The EDE will also publish and update an “approved pharmacopoeia” for the UAE, setting essential quality requirements and manufacturing guidelines. A national system for tracking and coding medical products from manufacturer to end-user will also be established to bolster safety and authenticity.
Advertising of medical products will continue to require official approval, now from the EDE, with the new law providing more detailed conditions for granting such approvals. Furthermore, stricter provisions have been introduced for the import and export of medical products, requiring permits, enhanced documentation, and increased oversight by the EDE to combat counterfeit or substandard goods.
To underscore compliance, the law imposes significantly harsher penalties for violations, including fines of up to AED 1 million (approximately $270,000 USD) and longer imprisonment terms. The EDE is empowered with greater enforcement capabilities, including conducting inspections, seizing non-compliant products, suspending or cancelling licenses, and shutting down establishments in violation of regulations.
Entities and individuals subject to the new law have been granted a one-year grace period to achieve compliance, unless this period is extended by the Council of Ministers. Medical stakeholders are advised to closely monitor the forthcoming executive regulations and EDE decisions, which are expected to provide further detailed guidance on various aspects, including MA approvals, fast-track applications, regulatory protection, and pharmacovigilance standards.