Guide on New Era of Pharmaceutical Regulation in the UAE

New Era of Pharmaceutical Regulation in the UAE: Changes to Federal Law No. 38 of 2024

For quite a while now, the United Arab Emirates has led in health care and pharmaceutical innovations across the Middle East. The UAE government passed Federal Law No. 38 of 2024, which became effective on January 2, 2025, to uphold its status as the regional leader in the pharmaceutical sector, thereby adhering to strict guidelines regarding patient safety. This law effectively replaces Federal Law No. 8 of 2019 and profoundly raises the bar in terms of legislation related to pharmaceuticals, pharmacists, and pharmaceutical institutions in the country.

The law will enhance the safety of patients, oversight from regulators, and efficiency in the market with encouragement for innovation and investment in the pharma sector of the UAE. Some of the main provisions include the establishment of EDE, new nomenclature for medical products, enhanced marketing approval scheme, and certain intellectual property protection measures. Moreover, it further introduces stricter pharmacovigilance standards, widened compliance responsibility, and severe penalties in case of non-compliance.

The article explains the salient provisions, compliance obligations, and implications of this law on the pharmaceutical sector of the UAE in detail.

Objectives of Federal Law No. 38 of 2024

This law is an essential step for the UAE toward achieving its greater vision of being a hub in the pharmaceutical and healthcare sectors. These objectives include the following:

      i.        Pharmaceutical Regulation Enhancement

Building a modern, transparent regulatory structure that will maintain market integrity and protect patients.

    ii.        Pharmaceutical Security

Guarantee all pharmaceutical products adhere to the required standards from production through supply to consumers in respect of their quality and safety.

   iii.        Encourage Investment and Innovation

Promote Foreign Direct Investment and Pharmaceutical Innovation, domestic through IP Protection

   iv.      Regulation of Pharmaceuticals Harmonization

The regulatory regime in place to standardize and ensure harmony of pharmaceutical rules within the international frameworks and models in existence across the world. It aims to comply with best global practice by other health-related entities including WHO, US FDA, EMA.

    v.       Improve Public Health Outcome

Ensure drugs and medicines and medical products entering the UAE market adhere to rigorous standards of safety, efficacy, and quality.

Main Provisions of Federal Law No. 38 of 2024

     I.   Establishment of Emirates Drug Establishment (EDE)

Establishment of Emirates Drug Establishment or EDE marks the most monumental reforms under this new law where the pharmaceutical regulation is being brought together into one place. The Emirates Drug Establishment EDE now administers:

i.              Approval and registration of pharmaceutical products.

ii.            Pharmacovigilance and monitoring of adverse events.

iii.           Market surveillance to ensure quality standards.

iv.           Development of the UAE Pharmacopeia, a national reference for drug quality and safety.

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