Pharmacovigilance services in UAE

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in the UAE, explore DDReg’s pharmacovigilance services in UAE to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to alignment with MOHAP pharmacovigilance regulations, the right PV partner shapes everything: signal detection, risk management planning, safety reporting, and successful market authorisation.

The Ministry of Health and Prevention (MOHAP) is the national authority responsible for pharmacovigilance in the UAE. MOHAP oversees all PV activities, including the evaluation of pharmacovigilance plans, approval of the Qualified Person for Pharmacovigilance (QPPV), and enforcing rules based on guidelines such as the Arab Good Pharmacovigilance Practices (Arab GVP), and UAE-GVP which are modelled in part on EU GVP.

As a pharmacovigilance services provider in UAE, DDReg offers end-to-end pharmacovigilance consulting services in UAE, combining global expertise with local regulatory insight. We ensure full adherence to MOHAP GVP, Arab GVP, and other local safety requirements. Our service portfolio includes:

• + ICSR Processing & Submission
  • Triage of initial & follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases and other relevant databases, with integration of WHO Drug Dictionary (WHO DD) and MedDRA
  • Quality checks, medical reviews
  • Submission of cases per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation processes with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs in line with UAE requirements
  • Customized procedures to classify safety risks & deliver tailored risk management services
  • Assessment of potential risks, missing safety information
  • Implementation of supplementary measures (e.g., Post-Authorization Safety Studies [PASS])
  • Conveying risks via labelling such as SmPC & patient information leaflet (PIL)
• + Aggregate Reports
  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports, as well as regulatory agency website monitoring
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports, and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Pharmacovigilance Signal Management
  • Identification of new safety signals or changes in risk from ICSR database, literature, aggregate reports, regulatory websites
  • Use of in-house tools & databases for signal detection and tracking
  • Review of safety signals, recommendations by PV Risk Assessment Committees
  • Label update analysis
  • Preparation of signal management trackers and annual signal reports
• + Qualified Person / QPPV / Local Safety Responsible (LSR) / QPPV Services in UAE
  • Review of PSMF, Safety Data Exchange Agreements (SDEAs), PV SOPs, etc.
  • Approval & sign-off of Aggregate Reports, Signal Reports, RMPs
  • Retainer services for QPPV and deputy roles
  • Local safety responsible role: monthly reconciliations, signal surveillance meetings, medical review
  • Regular communication & compliance metrics
• + PV Quality Management System Oversight
  • PV audit & compliance to applicable MOHAP, Arab GVP guidelines and international standards
  • Mock audits, audit plan optimisation
  • Gap assessments of PV staff
  • Organizational training on safety audits and inspections