The UAE has enacted Federal Decree-Law No. 38/2024 (the “New Law”), a significant update to its pharmaceutical regulatory framework, replacing Federal Law No. 8/2019. This New Law aims to enhance the governance of medical products, the pharmacy profession and pharmaceutical establishments in the UAE.
The New Law came into effect on 2 January 2025. However, there is a one year grace period to comply with its provisions (which may be extended).
Some of the key changes are as follows:
1) Expanded regulatory scope: The New Law not only covers traditional medical and pharmaceutical products, it now also regulates medical devices, biopharmaceuticals, food supplements and cosmetics. Further, the range of pharmaceutical establishments now falling within the remit of this New Law has been expanded, so the types of entities the New Law now regulates includes pharmacies, laboratories, biobanks, manufacturing facilities, contract R&D companies, marketing offices, and medical warehouses and storage facilities.
2) New central authority: Emirates Drug Establishment (EDE) takes over from the Ministry of Health and Prevention (MOHAP) as the consolidating regulatory authority overseeing, among others, medical approvals and pharmacovigilance.
The New Law sets out numerous national databases and systems which it proposes the EDE shall create to record and track various data sets, such as (i) the circulation, tracking and coding of medical products from the manufacturer to the end user; (ii) data and information related to medical products, their technical specifications and pricing; and (iii) registers of pharmaceutical establishments and biobanks across the UAE. The New Law is scant on the details for when these will be up and running, how they will operate and how the systems will be linked across the various authorities, healthcare establishments and health practitioners. It is expected that further information on this will follow, which will most likely be in the executive regulations or another executive order. However, obligations on entities to use these systems is likely and so increased operational costs for compliance are to be expected.
3) Marketing Approvals: The New Law introduces new types of regulatory approval for products: (i) conditional marketing approval for orphan drugs or for treatment of rare diseases; (ii) emergency use authorisations; and (iii) a fast track pathway with simplified procedures for innovative medical products of therapeutic importance. More detail will be set out in the executive regulations.
4) Strengthened IP Protection: The New Law has provided for documents and data related to innovative products and innovative medical products containing at least one new active ingredient (which can be developed in the UAE or imported) to be subject to regulatory protection. More detail regarding the specific periods and mechanisms for such regulatory protection is to be set out in the executive regulations.
5) Enhanced Pharmacovigilance: The New Law sets out stricter obligations for pharmacovigilance obligations, including monitoring and reporting adverse events. The EDE will also establish and manage a national electronic system for receiving and documenting such reports of adverse events.
6) Stricter Penalties: The New Law sets out more severe disciplinary sanctions, which includes higher fines, imprisonment, suspensions and market bans for violations.
A key element of this New Law, as is usual in the UAE, is the requirement to obtain licences from the relevant authorities. The EDE has already been set up, however as at the date of publication of this article, the grant of licences and marketing approvals is still being carried out by other authorities, including MOHAP. Given the criticality of EDE’s approval for a significant number of activities to be carried out by those operating in the healthcare sector in the UAE, proactive engagement with the EDE from the outset is crucial.
The New Law has set out the intentions of the EDE as an overarching regulatory body, particularly with the establishment of various national databases. The details of this, together with a number of other obligations in the New Law, are to follow, and therefore the publication of the executive regulations are critical to understanding your compliance obligations in the UAE.
As the UAE's pharmaceutical landscape evolves, it is crucial for companies in the healthcare sector to remain informed and proactive. Stakeholders should review their current compliance practices and proactively engage with the EDE to ensure continued compliance and access to marketing approvals.
