Read the official EDE Circular No. 46/2026 and download the full regulatory document in the TOP-Pharma Resource Centre.

The Emirates Drug Establishment (EDE) has introduced a comprehensive regulatory framework for peptide products and substances under Circular No. 46/2026, Guideline for Handling Peptide Products and Molecules, issued on 5 November 2026. The 26-page document establishes requirements for regulatory approval, importation, pharmaceutical compounding, quality control, storage, traceability and the use of peptide-containing products in the United Arab Emirates.

The circular applies to medical products intended for clinical research, raw materials intended for pharmaceutical compounding, and products and materials intended for laboratory research. Finished peptide medical products holding a valid marketing authorisation or emergency-use authorisation issued by EDE, including earlier valid approvals issued by the Ministry of Health and Prevention (MOHAP), are excluded from its provisions and remain subject to the applicable requirements governing medical products in the UAE.

UAE regulatory pathways for peptide products and substances

Circular No. 46/2026 establishes four regulatory pathways based on the status and intended use of peptide products and substances:

• products holding a valid marketing authorisation in the UAE
• products approved by reference international regulatory authorities but not registered in the UAE, which may be considered for importation through the applicable legal pathways
• investigational products intended for authorised clinical trials
• substances intended exclusively for non-clinical laboratory research

Eligibility for pharmaceutical compounding is assessed separately and does not follow automatically from inclusion in any of these pathways.

Products intended for clinical research involving human subjects require product-related regulatory approval from EDE, together with clinical, research and ethical approvals from the competent health authorities and ethics committees. Research approval alone does not authorise the administration of laboratory substances to humans.

Materials intended for laboratory research may be used only for non-clinical purposes by appropriately licensed establishments. Products labelled “For Laboratory Research Use Only”, “Research Use Only” or “Not for Human Use” must not be administered to humans or used in preparations made by compounding pharmacies.

International regulatory approval does not replace the approval required from EDE for products falling within its regulatory jurisdiction.

EDE establishes a regulatory list of peptide substances

A central element of the circular is the EDE Peptide Regulatory List, included in its annex. The list identifies substances by scientific name, molecular form, route of administration, intended use, restrictions and quality specifications.

The annex distinguishes two regulatory categories.

Category 1 — Internationally authorised peptides

This category includes peptides that have received marketing authorisation in at least one recognised international regulatory jurisdiction, such as exenatide, dasiglucagon, setmelanotide, elamipretide, tesamorelin, bremelanotide and ziconotide. The annex also contains entries for other substances, including navepegritide, icotrokinra, calcitonin salmon, lixisenatide and thymosin alpha-1.

The list also specifies individual compounding conditions and quality requirements for substances including BPC-157 acetate, Epitalon acetate, KPV acetate, MOTS-c acetate, Semax and TB-500 acetate.

Category 2 — Investigational peptides

This category covers substances restricted to authorised clinical studies. They must not be used for routine prescribing, dispensing, compounding, sale or patient supply outside the applicable EDE-authorised research pathway.

The list includes retatrutide, cagrilintide, CagriSema, survodutide, pemvidutide, ARA-290 (cibinetide), kisspeptin-10, kisspeptin-54 and thymosin beta-4.

Inclusion in the annex does not constitute marketing authorisation or automatic permission for importation, compounding, supply, dispensing or patient use. All activities remain subject to the applicable EDE approval pathway, product classification, approved source and specifications, and any substance-specific restrictions. EDE may periodically amend, restrict, suspend or revoke listings when new safety or quality information becomes available.

New requirements for importation and supply chains

The circular introduces specific conditions for importing peptide products and raw materials.

Licensed medical warehouses may import pharmaceutical-grade peptide raw materials included in the annex only after obtaining prior EDE approval. These materials may be supplied exclusively to licensed compounding pharmacies.

Importers must verify the supplier’s status, the source and pharmaceutical grade of the material, the certificate of analysis for each batch, transportation and storage conditions, and supply-chain traceability up to the receiving establishment.

Peptide products intended for clinical research may be imported only after obtaining the necessary regulatory, technical and ethical approvals. Each shipment must be linked to the approved study protocol, sponsor and study site, with verification of source, quality, transportation conditions and traceability.

Materials intended for non-clinical laboratory research may be imported after verification of the receiving establishment, intended purpose and quantities. They must remain segregated and traceable and must not be diverted to human use.

The circular prohibits individuals from importing peptide products or substances for sale, distribution or circulation. Direct shipment from outside the UAE to consumers is also prohibited except through a licensed establishment and an applicable approved regulatory pathway, including personal importation where relevant.

Pharmaceutical compounding: restrictions and quality controls

Injectable peptide preparations may be compounded only by pharmacies licensed and qualified to prepare sterile products, in accordance with applicable pharmaceutical compounding requirements.

The use of research-grade materials or materials of unknown origin for compounding is prohibited.

Compounding pharmacies must document the clinical justification for preparation and verify the source, identity, concentration, impurities, degradation products, aggregates and stability of the materials. Testing must be appropriate to the associated risks and intended route of administration.

The circular explicitly states that a certificate of analysis or successful laboratory testing alone is insufficient to establish safety or clinical efficacy or to authorise human use.

Multi-peptide preparations require a documented assessment of formulation, compatibility, stability and safety, together with all necessary regulatory approvals.

The annex establishes minimum analytical requirements for peptide active substances and compounded finished products. These include identity, assay, peptide purity, related impurities, aggregation, residual solvents, elemental impurities and microbiological quality, with additional requirements for sterile preparations.

For peptide active substances, the default specifications include:

• Assay: 95.0–105.0%
• Peptide purity: not less than 98.0%
• Total peptide-related impurities: not more than 2.0%
• Individual unspecified impurities: not more than 0.5%

Product-specific or justified limits may apply under the conditions specified in the annex.

For compounded finished products, the requirements additionally cover dosage-unit uniformity, degradation products, particulate matter, sterility, bacterial endotoxins, container-closure integrity and other controls appropriate to the pharmaceutical form and route of administration.

Existing stocks, quarantine and traceability

Healthcare and pharmaceutical establishments must conduct an inventory of peptide products and substances covered by the circular, classifying them according to regulatory status, source and intended purpose.

Inventory lists must be submitted within 30 days of the circular’s issuance. Pharmaceutical establishments submit their lists directly to EDE or to the competent health authority, while healthcare establishments submit theirs to the relevant local health authority for referral to EDE.

The continued circulation and use of existing peptide products and substances must be assessed in accordance with the applicable federal requirements and any additional instructions issued by the competent local health authorities. Their presence in the UAE market does not, in itself, establish that they may continue to be used or supplied. Products of unknown origin, products not authorised for their intended use, and materials held for compounding despite being ineligible for that purpose must be segregated and placed in secure quarantine pending an EDE decision.

The circular establishes requirements for the assessment and handling of existing stocks. However, local authorities may impose additional measures. In Dubai, for example, the Dubai Health Authority instructed healthcare facilities under its jurisdiction on 10 November 2026 to stop using, prescribing, dispensing or handling the covered peptide products and compounded preparations covered by its instructions and to place them in quarantine immediately. Facilities were also instructed to submit an inventory by 5 December 2026.

EDE will assess submitted inventories and determine the appropriate regulatory action according to the associated risks and the nature of the non-compliance. Quarantined stock may be subject to re-exportation, disposal or another regulatory measure. It must not be returned to circulation without EDE’s prior written approval.

Healthcare facilities must also provide clinical follow-up for patients exposed to the affected products and ensure that appropriate therapeutic alternatives are available where necessary.

Importers, distributors and pharmaceutical and healthcare establishments must maintain complete records covering product identity, formulation, manufacturer, supplier, approvals, batch certificates of analysis, quantities received and used, recipients, transportation and the final disposition of products.

Compounding pharmacies must additionally retain prescriptions, clinical justifications, dose calculations, preparation records, test results, release documentation and traceability data linking each preparation to the individual patient.

Records must be retained for at least five years or for a longer period where required by applicable legislation.

Advertising, electronic sales and pharmacovigilance

The circular introduces additional restrictions on the promotion and electronic circulation of peptide products.

Advertising or promoting peptide products not authorised for human use, or presenting research materials as therapeutic products, is prohibited.

Misleading claims relating to anti-ageing, cellular regeneration, immunity, energy, concentration, weight loss, muscle building, performance, appearance or general health are also prohibited.

Compounded peptide preparations must not be represented as equivalent to approved medical products or described using claims implying guaranteed safety or efficacy.

Electronic supply and dispensing of compounded peptide preparations are permitted only through licensed pharmaceutical establishments authorised for the relevant activity, against a valid prescription and following pharmaceutical review and applicable regulatory requirements. Direct sales to consumers through unauthorised websites, applications, social media or other electronic platforms are prohibited.

Healthcare professionals and healthcare and pharmaceutical establishments must report adverse events, quality defects, suspected falsification, unlawful supply and advertising that does not comply with the guideline. Reports must include available information about the substance, product, formulation, concentration, route of administration, batch number, source and preparing establishment.

Responsibilities of EDE and local health authorities

The circular distinguishes the responsibilities of the federal regulator and local health authorities.

EDE is responsible for classifying peptide products and substances, determining regulatory pathways, evaluating evidence of quality, safety and efficacy according to intended use, verifying sources and specifications, and issuing the necessary federal approvals and permits within its jurisdiction.

Local health authorities are responsible for establishing and approving clinical guidelines and protocols governing peptide use within their respective jurisdictions. These include indications, patient selection, prescribing and administration requirements, follow-up and monitoring. They also supervise healthcare professionals and facilities under their authority.

Implementation deadlines under EDE Circular No. 46/2026

Circular No. 46/2026 entered into force on 5 November 2026, the date of its issuance. The implementation provisions establish the following deadlines:

• Immediately: quarantine non-compliant products and materials
• Within 30 days of issuance: healthcare and pharmaceutical establishments must submit inventory lists
• Within 15 days of receipt: health authorities must refer the submitted inventory lists to EDE
• According to the deadline specified by EDE: complete recall actions and submit the relevant report

The circular also requires the recall of peptide-containing products and substances imported, compounded or marketed in the UAE without prior regulatory approval from EDE.