In brief
To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 20231. 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.
More background
Medical products regulated by the EDC
The medical products that fall within the competencies of the EDC are:
- Medicinal products (whether human or veterinary)
- Medical devices
- Pharmaceutical products
- Healthcare products
- Bioproducts (vaccines, blood products, cell and gene therapy products)
- Nutritional supplements
- Cosmetics
- Veterinary products
- Fertilizers
- Agricultural improvers
- Plant growth regulators
- Pesticides
- Genetically modified organisms
Objectives of the EDC
The objectives of the EDC are to protect the public health and to make the UAE an international hub for pharmaceutical and medical industries by achieving the following:
- Promoting research and development and attracting investment in the pharmaceutical and medical products sector
- Enhancing local industrial capacity in the areas of development, production and export of high quality and cost effective pharmaceutical and medical products
- Supporting pharmaceutical security in the country and ensuring availability, effectiveness and safety of pharmaceutical and medical products
- Managing the local procedures of manufacturing, marketing and trading of medical products in accordance with best international standards and practices
Competencies of the EDC
Article 6 of the new law determines several competencies of the EDC, of which the main competencies are the following:
- Issue the national framework for and approve the entities that are entrusted to conduct drug research as well as clinical and non-clinical studies.
- Establish specialized research centers in partnership and coordination with hospitals, as well as the concerned academic, research and scientific institutions in the UAE and abroad.
- Conduct all stages of examinations for medical products, and accredit the laboratories that shall conduct, monitor and supervise the examinations of medical products.
- Approve, register and monitor medical products and issue marketing approvals.
- Establish the pricing system of medical products.
- Manage the requirements for good manufacturing and innovation of medical products.
- Issue licenses to factories, pharmacies, medical product companies, pharmaceutical consultancy offices, warehouses, marketing offices (scientific offices), blood banks, stem cells and cord blood banks, and manage compliance with the relevant licensing controls and standards.
- Issue permits related to import, export, re-export, manufacturing, selling, distributing, offering, acquiring, trading, storing and disposing of medical products, including controlled and semi-controlled products and precursors.
- Establish a national database for pharmacogenomics in order to develop more effective drugs and treatments.
- Develop the national pharmacovigilance system in order to ensure the quality, effectiveness and safety of medical products.
- Develop the national policy related to the determination of the strategic stock of drugs and medical supplies.
- Organize, manage, and protect the confidentiality of medical product data.
- Propose to sign international treaties and conventions, and propose or accede to MoUs and agreements with regional and international organizations.
- Represent the UAE in regional and international organizations, exhibitions and conferences.
- Establish and manage a comprehensive database for data and information related to the competencies of the EDC, in coordination with the MOHAP and the health authorities.
- Impose administrative penalties relating to violations of the laws and regulations related to medical products.
Noteworthy, the EDC, upon the approval of the UAE Cabinet, may delegate some of its competencies to any federal or local government entity and to outsource some of its tasks and services to any other government or private entity.
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 above or your usual Baker McKenzie contact.
1 Federal Decree No 28 of 2023 of 25 September 2023 establishing the Emirates Drug Corporation
