The Ministry of Health and Prevention (MoHAP) has announced the transfer of a set of its services to the Emirates Drug Establishment (EDE), as part of its ongoing efforts to develop the healthcare services ecosystem and enhance the efficiency of regulatory frameworks governing the pharmaceutical sector.

The strategic move aims to unify mandates, clarify institutional roles, and strengthen integration among relevant government entities, positively impacting customer experience and ensuring the continuity of services with greater efficiency and flexibility.

Falling under an integrated institutional approach, this organisational change is set to realign regulatory and supervisory roles within the healthcare sector in line with evolving health legislation, strengthen governance effectiveness, and ensure clarity regarding the authority responsible for each service, particularly in areas related to the regulation of medicines, medical supplies, and associated health products.

The Ministry implemented the service transfer in phases, in coordination with the Emirates Drug Establishment, to ensure smooth procedures and facilitate transactions for service users.

The restructuring includes the full transfer of 44 core services to the Emirates Drug Establishment, which will now be solely responsible for their administration, regulation, and oversight under its approved legislative mandate.

These services include the re-pricing of individual medical products; the registration and renewal of manufacturers of medical products; the issuance of certificates for pharmaceutical products intended for export; the renewal of registration for pharmaceutical products derived from natural sources; the publication of price lists for regulated medicines; the issuance of accreditation certificates for clinical studies or bioequivalence centres; and the issuance of certificates reflecting amendments to registered pharmaceutical products.

Additional services falling under the authority of the Emirates Drug Establishment include the analysis of medical products for pharmaceutical companies and their subsidiaries; the issuance of quality reports for medical products by drug quality control laboratories; the approval of pharmacovigilance officers for pharmaceutical establishments; the approval of pharmacovigilance plans for medical products; the publication of price lists for controlled and semi-controlled drugs; authorisation for pharmaceutical entities to destroy drug products; and requests for the registration of custody records for controlled or semi-controlled drugs.

As for the services that the Ministry of Health and Prevention transferred partially to the Emirates Drug Establishment, this was carried out within a framework that distributes roles and responsibilities in line with the nature of each service and its regulatory requirements, ensuring regulatory integration and avoiding duplication of procedures.

This category includes 13 services, namely: the licensing, renewal, reactivation, amendment, and cancellation of pharmaceutical facility licences; the publication of the list of licensed pharmaceutical facilities in the UAE; the issuance and renewal of health advertising licences; the handling of appeals against health advertising violations; the receipt and processing of complaints against private health facilities and their medical personnel; the approval of emergency drugs and psychotropic substances; requests for the handover of custody of narcotic drugs; the approval of authorised signatories responsible for narcotic drug custody; and requests for the registration of narcotic drugs distributed to private health establishments.

The third category comprises five services related to the pharmaceutical sector that remain fully within the jurisdiction of the Ministry of Health and Prevention. These services include the issuance of controlled-medicine prescription books; authorisation of narcotic drug custody for hospitals; determination or modification of narcotic drug quotas for private healthcare facilities or pharmaceutical establishments; approval of narcotic drugs for in-house pharmacies in private hospitals; and approval of narcotic drugs for day-surgery centres. The Ministry will continue to deliver and oversee these services in accordance with the approved regulatory frameworks.

MoHAP stressed that the transfer of services to the Emirates Drug Establishment is part of its commitment to building a fully integrated and cohesive healthcare ecosystem that places customers and partners at the top of its priorities.

The move will also ensure clear mandates and communication channels while safeguarding the smooth and efficient continuity of services, in line with the objectives of the Zero Government Bureaucracy Programme, which aims to simplify procedures and accelerate service delivery.

The Ministry noted that it will continue to accelerate efforts to develop a more efficient, flexible and integrated healthcare system capable of keeping pace with rapid transformations, enhancing quality of life, and strengthening cross-government collaboration through robust institutional governance and effective coordination.

These efforts, the Ministry said, are guided by established standards of quality and efficiency across all stages of service delivery, enhancing system readiness and reinforcing customer confidence in line with the “We the UAE 2031” vision.

MoHAP added that the transfer of several services to the Emirates Drug Establishment does not represent a change in its commitments to customers but rather a redistribution of responsibilities in accordance with governing legislation. This approach not only enhances the flexibility of the healthcare system and improves the customer journey by reducing points of contact, but also accelerates decision-making cycles, and unifies regulatory reference points, thereby limiting procedural overlap and strengthening the predictability of regulatory requirements.

The Ministry called on customers, pharmaceutical companies and professionals working in the pharmaceutical sector to rely on the approved official channels to obtain information and updates and to submit enquiries, supporting effective communication, strengthening regulatory compliance, and contributing to the operational sustainability of services aligned with global best practices, in pursuit of a healthier future for the UAE.