If you are considering setting up a pharmaceutical factory in the UAE, the regulatory framework has recently undergone a significant change. A number of pharmaceutical licensing and GMP oversight functions have transitioned from the Ministry of Health and Prevention (MOHAP) to the Emirates Drug Establishment (EDE). If your compliance plan is still written on the old structure, now is the time to update it.

UAE pharmaceutical manufacturingThis guide provides a practical overview of the requirements. It explains who regulates what, what a factory needs to get licensed, and what GMP looks like on the ground.

Meet the Emirates Drug Establishment (EDE)

The Emirates Drug Establishment (EDE), the UAE’s independent federal authority for pharmaceuticals and medical devices, was established in September 2023 under Federal Decree-Law No. 28 of 2023. Its scope covers all medical and pharmaceutical products manufactured in the country, including medical devices and other medical-product categories within its statutory mandate.

A further regulatory shift followed. Federal Decree-Law No. 38 of 2024 entered into force on 2 January 2025, replacing the older Federal Law No. 8 of 2019. As part of the implementation of this transition, MOHAP announced the full transfer of 44 core services to EDE, together with the partial transfer of 13 additional services, including pharmaceutical-facility licensing functions. EDE now administers medical-product factory licensing and GMP certification through its regulatory services.

MOHAP still exists. It continues to retain specific pharmaceutical-sector responsibilities, including licensing medical professionals and pharmacists supporting EDE-licensed establishments, as well as certain controlled-medicine functions. Abu Dhabi also maintains its own Approved Drug List and processes for certain non-registered medicines within the local healthcare system through the Department of Health (DOH); these are distinct from the federal EDE manufacturing-licensing process. So a manufacturer operating across emirates may need to coordinate with federal and relevant local authorities depending on the project and market pathway, rather than dealing with only one authority.

Why This Matters for Facility Planning

EU GMP approvalThis is an important distinction during regulatory and facility planning. While pharmaceutical facility licensing and in the UAE are processed at the federal level, specific healthcare-market requirements in Abu Dhabi are managed by the DOH. If your plant is in Dubai, you work with the EDE for manufacturing approval. Separate emirate-level requirements, such as industrial, environmental, municipality and Civil Defence approvals, may also form part of the overall project pathway. If your products are intended for specific Abu Dhabi healthcare channels, applicable DOH requirements become an additional local-market consideration.

This is not a sequence in which one approval leads automatically to the next. These are different regulatory and project-approval tracks and early planning saves a lot of back and forth later.

Core UAE Pharmaceutical Manufacturing Requirements

Whether you are setting up a new plant or expanding an existing one, the basic route to a pharmaceutical manufacturing licence in the UAE goes through a few stages.

Stage 1: Initial Approval and Site Planning

The applicant will provide company and site information for review before construction. This includes the ownership structure, corporate documents, project feasibility information and the documentation required for initial regulatory review. Current EDE requirements place the proposed pharmaceutical dosage forms and production lines under the subsequent construction and preparation stage rather than the initial-approval documentation.

Stage 2: Construction and Preparation

After the initial approval is obtained, the facility begins to build out the physical plant. Detailed engineering drawings, approval related to estimated water and electricity consumption where required, a list of the pharmaceutical forms and proposed production lines, the equipment and devices for each production, packaging, and sterilisation line where applicable, and an explanation of what the quality control laboratory needs to operate are required at this stage. Then, once these documents have been submitted and the relevant requirements fulfilled, the facility will be eligible to submit a GMP inspection request through EDE.

Read more at 👍https://www.pharmaaccess.net/blog/uae-pharmaceutical-manufacturing-requirements-ede-gmp-and-facility/

UAE Pharmaceutical Manufacturing Requirements: EDE, GMP, and Facility Readiness Explained

If you are considering setting up a pharmaceutical factory in the UAE, the regulatory framework has recently undergone a significant change