Emirates Drug Establishment Charts Ambitious Growth in Pharmaceutical Sector During First Half of 2026
The Emirates Drug Establishment has delivered significant regulatory achievements, approving 942 new products and conducting over 2,000 inspections whilst fostering local manufacturing and international investment in the UAE's thriving pharmaceutical landscape.
The Emirates Drug Establishment (EDE) has demonstrated substantial progress in advancing the UAE’s pharmaceutical sector during the opening months of 2026, implementing a comprehensive transformation that integrates regulatory evaluation, marketing authorisation, inspection protocols and pharmacovigilance functions.
The organisation conducted 2,030 inspection and regulatory visits across pharmaceutical warehouses, marketing offices and local manufacturing facilities throughout the first half of the year, culminating in 288 visits during June alone. These inspections extended across the pharmaceutical, agricultural and veterinary sectors, encompassing facilities under EDE supervision and encompassing monitoring of medical product disposal and good practice compliance.
Within the sphere of advertising regulation, EDE identified 828 non-compliant pharmaceutical advertisements during the same period, including 113 instances in June, demonstrating rigorous market oversight.
The regulatory framework itself underwent substantial evolution, with Federal Decree by Law No. (21) of 2025 Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments taking effect on 1st January 2026. The EDE Chairman issued six legislative decisions governing semi-controlled substances, administrative violations, pharmacovigilance practices, narcotic substance schedules, foot-and-mouth disease vaccines and essential veterinary medical products.
Product approvals reached 942 during the half-year period, comprising 420 conventional and biological pharmaceutical products—including 63 innovator treatments—alongside 376 healthcare products and 146 medical devices. Notably, locally manufactured products accounted for 247 approvals, representing more than a quarter of the total and reflecting the EDE’s commitment to supporting domestic pharmaceutical development.
The UAE achieved global recognition through several landmark approvals: Inpefa and Foundayo secured authorisation as only the second country worldwide to approve each treatment; EURneffy became the region’s first epinephrine nasal spray for severe allergic reactions; Baxfendy earned distinction as the first global approval for uncontrolled hypertension; and MIEBO achieved authorisation as the third country globally to approve this dry eye treatment.
The EDE established a national task force convening 16 pharmaceutical and logistics sector entities to coordinate responses to emerging challenges and enhance inventory management. In February, the organisation implemented a mechanism requiring pharmaceutical companies to appoint multiple importers for each marketed product, strengthening supply resilience.
International investment has reflected growing confidence in the UAE’s regulatory environment. Novo Nordisk’s establishment of a regional distribution centre will serve as one of three global facilities managing product distribution across approximately 70 countries throughout the Gulf, Africa and Central Asia.
The organisation’s engagement with international platforms, including participation in World Health Expo 2026 and Make it in the Emirates 2026, underscores the UAE’s emerging position within global pharmaceutical regulation and research.
Source: WAM