Pharmacovigilance Services in Mexico

Whether you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Mexico, access to pharmacovigilance services in Mexico is critical to ensuring drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with COFEPRIS pharmacovigilance regulations, the right PV partner shapes everything, signal detection, risk management planning, safety reporting, and successful market authorization.

Expert Pharmacovigilance Services for the Mexico Market

Mexico is one of Latin America's foremost markets for medicinal products and medical devices. The Federal Commission for Protection Against Sanitary Risk (COFEPRIS) and the National Pharmacovigilance Center (CNFV) form the core of the country's pharmacovigilance framework, overseeing adverse drug reaction (ADR) reporting from healthcare professionals, consumers, manufacturers, and clinical trial sponsors.

Mexico employs the unique VigiFlow tool for ADR notifications, enabling seamless receipt, processing, and analysis of ADR data, which is then transmitted to the WHO/UMC global database.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, including SUSARs
  • Processing through E2B(R3)-compliant databases integrated with WHO DD and MedDRA
  • Quality checks and medical reviews
  • Submission to COFEPRIS within regulatory timelines
  • Tracking and reconciliation with clients
• + Risk Management Plans (RMP / REMS)
  • Drafting, reviewing, and maintaining customized RMPs
  • Risk classification, assessment of missing information, and mitigation strategies
  • Implementation of supplementary measures including PASS (Post-Authorization Safety Studies), targeted follow-up, and educational tools
  • Communication of risks via SmPC and PIL
• + Aggregate Reports
  • PSURs, PBRERs, PADERs, DSURs, ASRs
• + Signal Management
  • Identification of new safety signals from ICSRs, literature, and regulatory monitoring
  • Signal review, label update analysis, and PRAC recommendations
  • Development of signal trackers and annual signal reports
• + Local Pharmacovigilance Responsible Person in Mexico
  • PSMF review, SDEA agreements, SOP oversight
  • Aggregate report and signal report sign-off
  • Retainer-based QPPV and deputy support
  • Signal surveillance meetings and compliance reporting
• + PV Quality Management System Oversight
  • PV audits and compliance checks aligned with NOM-220-SSA1-2016
  • Gap assessments, audit plans, and mock inspections
  • Organizational training for PV inspection readiness