UAE Healthcare Regulation Update As MoHAP Transfers Key Services To Emirates Drug Establishment

The Ministry of Health and Prevention has reallocated a large group of pharmaceutical services to the Emirates Drug Establishment, restructuring responsibilities across the UAE healthcare system. The step is designed to clarify mandates, align with updated health legislation, and streamline regulatory oversight, while keeping service delivery stable, more efficient, and easier to navigate for patients, companies, and healthcare providers.

According to the Ministry, this redistribution does not alter its obligations towards customers but changes how these duties are shared with the Emirates Drug Establishment. The new model reduces overlapping procedures, shortens decision cycles, and decreases the number of entities customers must approach, which is expected to provide clearer regulatory reference points across the pharmaceutical sector.

The transfer is part of an integrated institutional framework aimed at creating a more cohesive healthcare ecosystem. It supports the objectives of the Zero Government Bureaucracy Programme, which targets simpler procedures and faster service completion. By aligning regulatory roles among government bodies, the authorities intend to improve governance, elevate service quality, and maintain continuity while ensuring that accountability for each service is clearly defined.

MoHAP confirmed that the move responds to rapid shifts in healthcare needs and regulation. The Ministry aims to keep the UAE healthcare system flexible and resilient, while strengthening coordination among entities involved in medicines, medical supplies, and related health products. These efforts are guided by recognised benchmarks for service quality and efficiency, helping maintain readiness and sustain customer and partner confidence.

The Ministry implemented the transfer in stages, in close coordination with the Emirates Drug Establishment, to avoid disruption. This phased approach supported smooth handover of responsibilities, protected service continuity, and allowed both institutions to adjust internal processes. It also helped customers adapt to new channels and procedures without confusion or delays in completing regulatory transactions.

Under the restructuring, 44 core pharmaceutical services are now fully assigned to the Emirates Drug Establishment. The Establishment will handle administration, regulation, and oversight of these services under its approved legislative mandate. By assigning these activities to one authority, policymakers expect more consistent supervision, better integration of data, and clearer communication with stakeholders in the pharmaceutical market.

Emirates Drug Establishment services and core regulatory functions

Among the fully transferred services are the re-pricing of individual medical products and the registration and renewal of manufacturers of medical products. The Emirates Drug Establishment will also issue certificates for pharmaceutical products designated for export and handle renewal of registration for medicines derived from natural sources, in addition to publishing price lists for regulated medicines across the UAE market.

The Establishment will issue accreditation certificates for clinical studies and bioequivalence centres and provide certificates for amendments to registered pharmaceutical products. Other transferred services include laboratory testing of medical products for pharmaceutical companies and subsidiaries, and the issuance of quality reports from drug quality control laboratories, which underpin regulatory decisions and market surveillance responsibilities.

Emirates Drug Establishment services and pharmacovigilance, pricing, and disposal

Pharmacovigilance-related activities are now also under the Emirates Drug Establishment. These include approving pharmacovigilance officers within pharmaceutical establishments and endorsing pharmacovigilance plans for medical products. The Establishment will publish price lists for controlled and semi-controlled medicines, authorise pharmaceutical organisations to destroy drug products, and oversee requests to register custody records for controlled or semi-controlled drugs.

Some responsibilities have been divided rather than completely transferred. Thirteen services now operate under a shared model between the Ministry and the Emirates Drug Establishment, aligning duties with each service’s regulatory nature. This distribution aims to avoid duplication while keeping oversight robust, especially in areas that affect public safety, commercial operations, and regulatory compliance for private healthcare facilities.

Emirates Drug Establishment services and shared licensing responsibilities

The shared services include licensing, renewal, reactivation, amendment, and cancellation of pharmaceutical facility licences, alongside publication of the list of licensed pharmaceutical facilities in the UAE. Issuing and renewing health advertising licences, handling appeals against health advertising violations, and processing complaints against private health facilities and their medical staff also fall within this partly transferred group.

Further shared services cover approval of emergency medicines and psychotropic substances, requests for handover of custody of narcotic medicines, approving authorised signatories responsible for narcotic custody, and registering narcotic medicines distributed to private healthcare establishments. Roles within these services are divided between MoHAP and the Emirates Drug Establishment based on regulatory function and legal mandate.

Emirates Drug Establishment services and MoHAP-retained narcotics oversight

Five services in the pharmaceutical field remain fully under the Ministry of Health and Prevention. These cover issuing prescription books for controlled medicines, approving narcotic drug custody for hospitals, and setting or adjusting narcotic medicine quotas for private healthcare facilities or pharmaceutical establishments. The Ministry will also approve narcotic medicines for private hospital in-house pharmacies and day-surgery centres.

MoHAP emphasised that it will continue to advance a more efficient, integrated healthcare system aligned with the "We the UAE 2031" vision. The Ministry encouraged customers, pharmaceutical companies, and sector professionals to rely on official channels for information, enquiries, and updates, supporting regulatory compliance and helping maintain sustainable, globally aligned services across the UAE healthcare and pharmaceutical landscape.

With inputs from WAM