Middle East Healthcare & Life Sciences: 2026 Summer Round-Up and the Season Ahead

Since our last update, the healthcare and life sciences sector across the United Arab Emirates (UAE) and the wider Gulf has continued its rapid regulatory evolution.

Over the summer months, we have seen a significant new pharmacovigilance framework take effect, an expanded national organ donation and transplantation incentive scheme, continued momentum behind pharmaceutical manufacturing localisation, and further consolidation of oversight under the Emirates Drug Establishment (EDE). At the same time, the calendar for the remainder of 2026 is exceptionally full, with a series of confirmed regional gatherings set to bring together policymakers, investors, clinicians and legal practitioners across the region.

In this note, we provide a summer round-up of the key legal and regulatory developments affecting the sector, before looking ahead to a busy final quarter of the year and the themes we expect to define it.

1. Regulatory round-up for summer 2026

The new Good Pharmacovigilance Practice Guideline

On 27 July 2026, the EDE published Resolution No. 27 of 2026 approving the Good Pharmacovigilance Practice Guideline for Medical Products (the GVP Guideline), filling a gap that practitioners had flagged since Federal Decree-Law No. 38 of 2024 on Medical Products, Pharmacists and Pharmaceutical Establishments took effect. The GVP Guideline moves pharmacovigilance in the UAE from a general statutory obligation to a detailed, inspectable compliance framework. It applies to pharmaceutical products, healthcare products, food/dietary supplements, and cosmetics with a medical effect, but it does not extend to medical devices, veterinary products or biobank samples.

Key obligations for Marketing Authorisation Holders (MAHs) include inter alia:

• Appointing a Qualified Person for Pharmacovigilance and a deputy, both of whom must be UAE residents, hold at least a bachelor's degree in pharmacy or medicine, and demonstrate adequate theoretical and practical pharmacovigilance training. Where a foreign MAH has no licensed UAE marketing office, the qualified person may instead sit within a licensed medical warehouse appointed by the MAH;
• Maintaining a national pharmacovigilance system file and/or master file, covering roles and responsibilities, organisational structure, quality management, and training records;
• Operating a Risk Management System, including a Risk Management Plan built around seven core modules (product information, safety specification, pharmacovigilance plan, post-authorisation efficacy studies, risk minimisation measures, summary, and annexes) – mandatory for innovative and biosimilar products, and available to be requested by the EDE for any other product based on its risk profile;
• Reporting serious adverse effects within 5 days (initial report) and 15 days (final report), and non-serious effects within 90 days, using the prescribed formats via the EDE's electronic portal;
• Submitting Periodic Safety Update Reports within specific timeframes to EDE;
• Maintaining risk minimisation measures (routine and, where necessary, additional measures such as educational materials or patient alert cards) and a functioning signal management process; and
• Cooperating with routine and risk-based GVP inspections conducted by the EDE, and addressing any resulting compliance or enforcement requirements.

The Guideline references Arab GVP Version 3, International Conference for Harmonization and European Medicine Agency guidance, reinforcing the EDE's intention for continued alignment with international regulatory standards.

MAHs, local distributors, importers and licensed medical warehouses handling medical products in the UAE should promptly benchmark their existing pharmacovigilance systems, QPPV appointments and SOPs against the new Guideline, given the EDE's stated intention to conduct both routine and risk-based inspections. From an M&A perspective, pharmacovigilance should also move higher up the diligence agenda for relevant pharmaceutical and consumer-health targets, including review of QPPV arrangements, pharmacovigilance system documentation, adverse-event reporting, risk-management plans and inspection history.

Expanding the organ donation and transplantation framework

Ministerial Decision No. 91 of 2026 introduces a state-backed package of 15 categories of incentive (10 in-kind, 4 medical and 1 insurance benefit) for living organ and tissue donors and the families of deceased donors, under the UAE's national ‘Hayat’ donation and transplantation programme. Benefits include comprehensive health insurance for living donors (per Article 9 of Federal Decree-Law No. 25 of 2023), coverage of donation-related medical costs, travel and accommodation support, and a priority-transplant provision for eligible donors and qualifying relatives.

MOHAP figures published alongside the Decision record 549 deceased donors and 1,780 transplants since 2017, with 2025 donor numbers up 35.5% year-on-year. For investors evaluating hospital platforms with transplant capabilities or ambitions, the evolving framework may increasingly be relevant to regulatory and operational diligence, including licensing, clinical capability, insurance coverage and the strategic positioning of specialist transplant programs.

Manufacturing localisation continues to accelerate

Mubadala Bio, the Mubadala-backed integrated biopharma and pharma logistics platform, has maintained an active pace of local manufacturing announcements over the summer months, including the launch of the first locally manufactured hemodialysis solutions in the UAE (July 2026) and an exclusive partnership with Biosidus to expand access to biologic therapies (June 2026). These developments sit alongside the continued build-out of Abu Dhabi's Health, Endurance, Longevity and Medicine (HELM) cluster, and reflect the UAE's sustained drive toward pharmaceutical security and onshore biosimilar and biologics production.

Continued consolidation under the EDE, and the National Unified Digital Licensing Platform

The EDE has now absorbed dozens of the core regulatory services previously split across MOHAP, DOH Abu Dhabi and DHA Dubai, continuing the shift toward a single federal authority for medicines, medical devices, blood derivatives and related life sciences products. The continued operationalisation of the EDE is progressively centralising federal regulation of medicines, medical devices and other regulated medical products, alongside the functions that remain with the emirate-level health authorities.

In parallel, MOHAP's National Unified Digital Platform for healthcare professional licensing, which will consolidate MOHAP, DOH, DHA and the newly autonomous Sharjah Health Authority under a single digital profile, is reported to remain on its confirmed Q2 2026 go-live target. Once fully rolled out, it is expected to deliver a single professional profile, reusable DataFlow/PSV verification, and genuine cross-emirate mobility for healthcare practitioners licensed in the UAE. Operators of multi-emirate hospital and clinic networks should monitor the rollout closely, given its likely impact on recruitment and staff redeployment.

Wider legal backdrop

Separately, the new UAE Civil Code (Federal Decree-Law No. 25 of 2025), which took effect on 1 June 2026 and replaces the 1985 Civil Transactions Law in its entirety, is directly relevant to healthcare providers, insurers and life sciences companies as counterparties to a wide range of UAE law governed arrangements. For healthcare and life sciences businesses, the change warrants particular attention in long-term supply and distribution arrangements, healthcare services contracts, indemnity and liability provisions and other UAE-law governed contracts entered into before or after the new Code took effect.

2. Looking ahead: a busy season through year-end

The remainder of 2026 brings an unusually dense calendar of confirmed regional gatherings. Between September and the end of 2026, the region's healthcare and life sciences calendar features several confirmed events across the UAE, spanning general medical conferences, specialty and disease-focused congresses, the laboratory and diagnostics trade event ARABLAB+ Live, and a cross-sector legal/investment gathering at the Law Middle East M&A Summit, with the flagship of the season being the Abu Dhabi Future Health Summit in October, the region's largest dedicated health innovation gathering.

Abu Dhabi Future Health Summit, being the annual flagship gathering of Future Health – A Global Initiative by Abu Dhabi, taking place at ADNEC Centre under the theme “To Sense Is to Predict” is expected to bring together some 16,000 attendees from over 100 countries, structured around four impact areas: longevity and precision medicine, health system resilience and sustainability, digital health and AI, and investment in life sciences. We will be attending and would be delighted to connect with anyone who is interested in discussing current topics.

Law Middle East M&A Summit is not healthcare-specific event but rather a gathering of the region's corporate law community. However, it will feature a dedicated panel on the growing role of warranty and indemnity (W&I) insurance in Middle East M&A – a topic of direct relevance to healthcare platform consolidation – with our own Roshanak Bassiri Gharb speaking alongside other panellists. We look forward to engaging discussions during the event.

3. Key themes we expect to define the months ahead

• Longevity and precision medicine as an increasingly investable asset class, with continued focus on the standardisation of outcomes, protocols and reimbursement models needed to earn insurer and investor confidence;
• Digital health, AI and health data infrastructure, including national data platforms, AI-enabled diagnostics moving into regulated care pathways, and the governance, cybersecurity and consent frameworks that must underpin them;
• Pharmacovigilance and regulatory readiness, as MAHs and distributors adapt to the new GVP Guideline ahead of anticipated EDE inspections;
• Manufacturing localisation and drug security, as the HELM cluster, Mubadala Bio and related initiatives continue to expand onshore biopharma capacity;
• Healthcare M&A, platform consolidation and W&I insurance, as deal activity continues and risk transfer solutions become a standard feature of transaction structuring;
• Workforce mobility and unified licensing, as the National Unified Digital Platform rollout reshapes recruitment and cross-emirate deployment of clinical staff; and
• Organ donation and transplant capacity as an emerging consideration in hospital M&A diligence and valuation.

Our Healthcare & Life Sciences team continues to monitor these developments closely and will be pleased to discuss any of the issues raised in this note, including their practical implications for your business. To discuss further reach out to Roshanak Bassiri Gharb, Partner | Julia Ofer, Partner, Member of Healthcare & Life Sciences Group.