Emirates Drug Establishment
The Emirates Drug Establishment will be responsible for managing and regulating medical products including pharmaceutical products, healthcare products, biologics, medical devices, food supplements, cosmetics, veterinary products, fertilisers, pesticides, agricultural additives, plant growth regulators, and Genetically Modified Organisms (GMOs) and their products, in the UAE, including the free zones.
The establishment will be also responsible for:
- preparing an integrated national framework for pharmaceutical research, clinical and non-clinical studies and trials in accordance with the best international standards and practices
- accrediting the entities and bodies authorised to conduct these researches and experiments, as well as monitoring them and supervising their compliance
- issuing licenses and monitoring medical product factories and companies, pharmacies, warehouses and marketing offices, blood banks
- issuing licenses related to import, export, re-export, manufacturing, sale, distribution, offering, possession, circulation, storage and disposal of medical products
- monitoring and supervising compliance with the licenses issued, in accordance with the relevant applicable laws, as well as issuing marketing authorisations for medical products and licensing their marketing advertisements
- developing and supervising the implementation of the national framework for testing of medical products in all their stages, as well as accrediting, and supervising laboratories testing medical products
- approving and registering medical products, as well as establishing a national pricing system for medical products in the country, and a national system for tracking and monitoring medical products from the manufacturer to the consumer
- developing a pharmacogenomics national database that contributes to producing effective and personalised treatments and medicines
- determining the level of the strategic stockpile of medicine, developing the pharmacovigilance system and supervising its implementation to ensure the quality, efficacy and safety of medical products
- developing policies, strategies and legislation related to medical products in the UAE, in coordination with Ministry of Health and Prevention and the relevant health authorities, and implementing them after the Cabinet's approval
- regulating and managing the data pertaining to medical products, in accordance with the highest standards of data protection and security.
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