The Emirates Drug Establishment (EDE) issued Circular No. 46/2026 to establish controls for the handling of peptide products and molecules in the United Arab Emirates. The 26-page guideline applies to peptide-containing medical products intended for clinical research, raw materials intended for pharmaceutical compounding, and materials and products intended for non-clinical laboratory research. Finished peptide medical products holding valid EDE marketing authorisation or emergency-use authorisation, including products covered by earlier valid approvals issued by the Ministry of Health and Prevention (MOHAP), are excluded.

The circular sets out regulatory approval pathways according to product status and intended use, and establishes requirements for importation, supply-chain controls and the EDE Peptide Regulatory List. The annex identifies peptide substances, their molecular forms, routes of administration, intended uses, restrictions and quality specifications. Inclusion in the list does not in itself constitute marketing authorisation or permission to import, compound, supply or administer a substance.

The guideline also regulates pharmaceutical compounding, including restrictions on research-grade and materials of unknown origin, requirements for sterile preparations, analytical quality controls and documentation. Further provisions address existing stocks, quarantine, traceability and record retention, advertising and electronic sales, pharmacovigilance reporting, and the respective responsibilities of EDE and local health authorities.

The circular entered into force on 5 November 2026. It requires the immediate quarantine of non-compliant products and materials, healthcare and pharmaceutical establishments to submit inventory lists within 30 days, and health authorities to refer those lists to EDE within 15 days of receipt. The document is relevant to pharmaceutical manufacturers, importers, distributors, licensed compounding pharmacies, healthcare facilities, healthcare professionals and regulatory affairs specialists operating in or supplying the UAE market.