In brief
To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 2023. As a new independent regulator, the EDC will replace the Ministry of Health and Prevention (MOHAP) for the regulation of pharmaceuticals and medical devices.
Besides medicines and medical devices the EDC will also be responsible for cosmetics, dietary supplements, GMOs, fertilizers, pesticides, agricultural conditioners and plant growth regulators. The EDC will also take over some competences from the Ministry of Climate Change and Environment (MOCCAE) in relation to these products.
The EDC aims to strengthen the country’s position as a global hub for pharmaceutical and medical industries, promoting research and development in this sector. In addition, the EDC will work to enhance the production, development and export of high-quality medical and pharmaceutical products, as well as ensuring the availability, quality, effectiveness and safety of these products.
Whereas the EDC establishing act has been effective since 30 September 2023, the transfer of responsibilities will take several months to complete: Assets, accreditations and employees of MOHAP and MOCCAE necessary to support the regulation of medical products need to be transferred to the EDC. During the transition, MOHAP and MOCCAE will continue to exercise the competences assigned to the EDC until the latter is ready to assume such responsibilities.
As a critical step in the implementation, the UAE Cabinet approved the formation of the board of directors of the EDC in December 2023 and assigned Her Excellency Dr. Fatima Alkaabi to carry out the duties of Director General of the EDC. With Dr. Alkaabi, the UAE not only appointed a woman in the top job, but also a leader in the field as she has held multiple senior positions in healthcare institutions (including Head of Hematology and Oncology Adult Services in Sheikh Khalifa Medical City and Director of Abu Dhabi Bone Marrow Transplant at Abu Dhabi Stem Cell Centre). The appointment clearly signals a drive for innovation.
In an early interaction with the pharmaceuticals, medtech and healthcare industry during a US-UAE Business Council meeting at the end of January 20242, Dr. Alkaabi highlighted that research and development in medical devices, new medicines and generics, genomics and gene therapy, as well as in healthcare technology, AI and pharmacovigilance, are key priorities for the EDC and funding has been allocated to the corporation to foster investment in R&D. She stressed that the EDC aims to have the private sector engaged in its mandate to ensure the regulatory environment remains attractive and will be looking at opportunities for public-private partnership. Relatedly, the EDC intends to offer opportunity for industry stakeholders to provide feedback on policies and regulations.
The EDC will be headquartered in Masdar City in the Emirate of Abu Dhabi, but may open offices in other locations inside or outside the UAE. Whereas there is no precise time frame set for the transition, Dr. Alkaabi expects the core of responsibilities to be transferred to EDC by the end of April 2024.
Companies are encouraged to monitor developments and consider opportunities to collaborate with the EDC as it shapes its mandate and the future of the pharmaceuticals and healthcare industry.
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To speak with us in relation to the new law on the EDC, or any healthcare regulatory matters or issues more generally, please feel free to contact one of the lawyers below or your usual Baker McKenzie contact.
