Introduction

In recent years, the significance of pharmacovigilance (PV) has grown dramatically, and the Ministry of Health and Prevention (MOHAP) of the United Arab Emirates (UAE) has reinforced its regulatory framework to meet this challenge. For marketing-authorisation holders (MAHs), manufacturers, distributors, healthcare providers and other stakeholders, establishing a robust PV system is no longer optional — it is a regulatory obligation.

In this blog, we’ll explore the key components of PV requirements in the UAE: the regulatory framework, building the PV system (roles & responsibilities), procedural obligations (reporting, plans, inspections) and ongoing governance. At the end we’ll summarise the key take-aways you should keep in mind.

1.Regulatory Framework & Governance

1.1 Legal Basis and Authority

The UAE’s regulatory landscape for pharmaceuticals and medical products has recently been updated with Federal Law No. 38 of 2024 (which replaces earlier legislation). This law emphasises enhanced pharmacovigilance and post-market surveillance. The primary authority responsible for PV oversight at the federal level is MOHAP. In specific emirates, there are also health-authority bodies (for example, the Dubai Health Authority (DHA) or the Department of Health – Abu Dhabi (DoH) that issue guidance on adverse event reporting requirements.

1.2 Purpose and Scope

The goal is to ensure that marketed medical products continue to meet safety, efficacy and quality standards in the real-world environment. Accordingly, MAHs and manufacturers must maintain systems for detecting, monitoring, assessing and minimising risks associated with their products. For example, the “Guidelines on Good Vigilance Practice (GVP)” issued by MOHAP lay out the expectations for systems, documentation, inspections and ongoing risk-management.

1.3 Key Stakeholders

Key stakeholders in the UAE PV ecosystem include:

• MAHs (Marketing Authorisation Holders) – must establish and maintain PV systems.
• Qualified Person for Pharmacovigilance (QPPV) / Local Contact Person – responsible for PV oversight in the UAE.
• Healthcare professionals and patients – obligated to report adverse drug reactions (ADRs) and other safety concerns.
• Regulatory authorities (MOHAP, DHA, DoH etc) – responsible for review, compliance monitoring, inspections and enforcement.

2.Building the Pharmacovigilance System: Roles & Responsibilities

2.1 Appointment of QPPV and Local PV Contacts

Under UAE regulations, the MAH must appoint a QPPV who is resident in the UAE, holds a recognised qualification (pharmacy or medicine) and has relevant pharmacovigilance experience. If the QPPV is based outside the UAE, there must be a designated Local Contact Person for Pharmacovigilance (LCPPV) in the UAE. The QPPV’s responsibilities include oversight of the PV system, ensuring timely reporting of adverse events, risk-management, compliance with regulations and serving as the regulatory point of contact.

2.2 Pharmacovigilance Plan & Documentation

Before or during drug registration the company must submit a PV plan for evaluation by MOHAP. This plan must define the MAH’s roles, organisational chart, quality management and risk-minimisation strategies. Additionally, the PV system must be documented via a Pharmacovigilance System Master File (PSMF), standard operating procedures (SOPs), risk management system, signal-detection process, audit and inspection plan.

2.3 Risk-Management & System Quality

The PV system must include:

• A risk-management plan: identifying known risks, potential risks (food-drug, drug-drug interactions) and risk-minimisation activities.
• Signal detection and assessment processes: monitoring for new or increased adverse events.
• Quality system for PV: internal audits, inspections, deviation handling, CAPAs.

2.4 Training & Competency

Personnel involved in PV (especially the QPPV and those reporting/adjudicating events) must be trained in PV practices (including local regulations). MAHs often invest in certification programs for PV professionals in the UAE and GCC region.

2.5 Oversight & Governance

The MAH must monitor compliance with its PV system, review the performance of the system periodically, respond to regulatory inspections and implement improvements as needed. MAHs may be inspected by MOHAP or other emirate-specific authorities for compliance with GVP.

3.Procedural Obligations: Reporting & Regulatory Interactions

3.1 Adverse Event Reporting

All suspected adverse drug reactions (ADRs), especially serious ones, must be reported timely to the health authority. The UAE (via DoH in Abu Dhabi) mandates that healthcare professionals report any suspected ADRs.
Key considerations:

• The identity of the medicinal product must include name and batch number (especially for biologics) to ensure traceability.
• Reporting mechanisms: Many authorities provide online e-notification tools.

3.2 Periodic Safety Update Reports (PSURs) & Benefit-Risk Reports

MAHs must submit periodic safety update reports (PSURs) or periodic benefit-risk evaluation reports (PBRERs) per the guidelines. These reports summarise cumulative safety data, signal detection outcomes, risk-minimisation measures and recommendations.

3.3 Plan Evaluation & Submission

When registering a medicine (or variation) in the UAE, the MAH must submit the PV plan as part of the registration dossier. MOHAP provides a service “Evaluation of Pharmacovigilance Plan for Medical Products within UAE” for this purpose.

3.4 Inspections, Audits & Enforcement

Regulatory authorities may inspect MAHs’ PV systems, review documentation (PSMF, SOPs, training records, audit reports), and enforce compliance. Non-compliance (e.g., failing to report serious ADRs, deficient PV systems) may lead to penalties, recall of licence, suspension etc.

3.5 Recall & Market Withdrawal Procedures

When a medicinal product shows serious safety defects, the authority can issue a recall or market withdrawal. For example, the DoH Abu Dhabi’s standard sets mandatory recall timelines by class (Class I, II, III) and formal reporting of recall activities by the MAH or distributor.

4. Ongoing Responsibilities & Good Practices

4.1 Continuous Monitoring & Signal Management

PV is not a one-time activity. MAHs must continuously monitor safety data (internal and external), handle signal detection and management, update risk-minimisation plans and communicate safety information to healthcare professionals and patients.

4.2 Communication & Transparency

Safety communications (e.g., Healthcare Professional letters, public alerts) must be part of the system. MAHs must have mechanisms for disseminating safety-related information in a timely and effective manner.

4.3 Training and Awareness for Healthcare Professionals

Healthcare professionals must be aware of ADR-reporting channels, know how to identify suspected adverse reactions and maintain product traceability (especially for biologics, batch numbers). Authorities emphasise patient education and involvement in reporting.

4.4 Audit, Review and System Improvement

Regular internal audits of the PV system, update of SOPs and remediation of identified system gaps are required to maintain compliance and improve patient safety.

4.5 Cross-Border & Global Considerations

For MAHs operating internationally, the UAE PV requirements must be aligned with global systems (e.g., ICH guidelines) while meeting local-specific demands (resident QPPV, UAE-based contact, local batch traceability, etc).

Key Takeaways

• Establishing and maintaining a compliant pharmacovigilance system in the UAE is mandatory for all marketing-authorisation holders and manufacturers.
• Key roles include a UAE-resident QPPV (or local contact), documented PV plan, PSMF, risk-management system and trained personnel.
• Procedural obligations include ADR reporting (individual case safety reports), PSUR/PBRER submission, plan evaluation by MOHAP, inspections and possible enforcement.
• Ongoing responsibilities include continuous monitoring, signal detection, safety communication, audits and system improvement.
• Align global PV systems with UAE-specific requirements (resident QPPV, local contact, online reporting systems, documentation in required format) to ensure readiness for inspection and compliance.

Authored By : Aya Anis, PharmD.-
Operation & Vendor Manager, Baupharma.