DUBAI, 22nd September, 2026 (WAM) — During the first half of 2026, the Emirates Drug Establishment (EDE) underwent a significant transformation in its regulatory performance, driven by the integration of evaluation, marketing authorisation, inspection, pharmacovigilance and drug safety, risk management and supply sustainability functions. At the same time, it continued to support local manufacturing, research and development, and the use of advanced technologies across the pharmaceutical sector.
Official data show that EDE carried out 2,030 inspection and regulatory visits to warehouses, marketing offices and local manufacturing facilities across the UAE by June 30, 2026, including 288 visits in June alone.
The visits covered a wide range of facilities under EDE’s supervision in the pharmaceutical, agricultural and veterinary sectors. They also included monitoring the disposal of medical products and inspections related to good practices.
The findings were also integrated into digital and analytical systems that support decision-making and improve the efficiency of follow-up.
In advertising oversight, EDE identified 828 non-compliant advertisements during the first half of the year, including 113 in June.
The first half of 2026 also saw further development of the sector’s legislative and regulatory framework, with Federal Decree by Law No. (21) of 2025 Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments coming into force on January 1, 2026.
The Chairman of EDE also issued six legislative decisions covering the regulation of semi-controlled medical substances and products, administrative violations and penalties, good pharmacovigilance practices, updates to schedules of narcotic and psychotropic substances, the regulation of foot-and-mouth disease vaccines, and the adoption of the national list of essential veterinary medical products.
Regulatory activity also included 20 decisions on the pricing of medical products, including price adjustments and reductions, as well as 38 circulars covering precautionary, voluntary and urgent product recalls, regulatory warnings, and measures related to import procedures, customs clearance, supply continuity and pharmacovigilance.
In February, EDE approved a mechanism requiring pharmaceutical companies to appoint more than one importer for each medical product marketed in the UAE.
EDE also formed a national task force bringing together 16 entities from the pharmaceutical and logistics sectors to coordinate responses to emerging challenges, share operational data and technical expertise, and enhance planning and inventory management.
During the first half of 2026, 942 products were approved. These included 420 Conventional & Biological pharmaceutical products, among them 63 innovator products, as well as 376 healthcare products and 146 medical devices.
Local manufacturing accounted for 247 UAE-made products, representing more than a quarter of the total. These comprised 200 conventional pharmaceutical products, 40 healthcare products and seven medical devices.
Among the products approved were Inpefa® (sotagliflozin) for heart failure and Foundayo (orforglipron), making the UAE the second country in the world to approve each treatment.
EDE also approved EURneffy®, the region’s first epinephrine nasal spray for the emergency treatment of severe allergic reactions, and Baxfendy (baxdrostat) for uncontrolled high blood pressure, making the UAE the first country in the world to approve the latter. MIEBO, a treatment for dry eye disease, was also approved, making the UAE the third country globally to authorise the therapy.
EDE announced that a research team at Insilico Medicine had developed ISM0387. The candidate is designed to target tumours associated with MTAP deletion. ISM0387 was developed using Insilico Medicine’s Chemistry42 generative chemistry platform.
During the first half of the year, EDE carried out a series of field visits to UAE-based pharmaceutical and medical supplies manufacturers. The visits focused on production capacity, quality systems, expansion plans and the localisation of advanced therapeutic technologies.
Working within an integrated national ecosystem that brings together regulatory, economic and logistics authorities, EDE has helped create an attractive environment for pharmaceutical investment and international partnerships.
Novo Nordisk’s decision to establish a regional distribution centre in the UAE will be one of three global centres managing the distribution of the company’s products worldwide. The facility is expected to serve up to 70 countries across the Gulf, Africa and Central Asia.
EDE participated in the World Health Expo 2026 and Make it in the Emirates 2026, promoting the UAE’s position in pharmaceutical regulation, scientific research and health technologies.
EDE’s performance during the first half of 2026 demonstrates the breadth of its role across regulation, evaluation, marketing authorisations, inspection, supply, manufacturing and research.
Source: Emirates News Agency