Pharmacovigilance Services in Philippines

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in the Philippines, access to Pharmacovigilance Services in Philippines is critical to ensuring drug safety and regulatory compliance. From adverse drug reaction reporting to signal detection and risk management planning, partnering with the right pharmacovigilance consulting firms or local pharmacovigilance partner Philippines shapes everything from safety surveillance to successful market authorization.

Expert Pharmacovigilance Services for the Philippines Market

The Food and Drug Administration (FDA) of the Philippines under the Department of Health is the national authority responsible for post-market safety surveillance and serves as the National Pharmacovigilance Center, overseeing the spontaneous reporting of suspected adverse drug reactions (ADRs) from manufacturers, healthcare professionals, consumers, hospitals, and public health programs.

Underreporting remains a challenge in the Philippines, partly due to limited awareness of the National Pharmacovigilance Center among healthcare professionals, reluctance stemming from complex reporting processes, and usability issues in the online system.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs and SUSARs
  • Case processing via E2B(R3)-compliant systems integrated with WHO Drug Dictionary (WHO DD) and MedDRA
  • Medical review and quality checks
  • Timely submission aligned with Philippines FDA pharmacovigilance requirements
  • ICSR tracking and reconciliation with clients
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS
  • Custom safety risk classification and tailored risk management strategies
  • Risk assessment, gap identification, and recommendation reports
  • Supplementary measures (e.g., Post-Authorization Safety Studies - PASS, observational tools, follow-up questionnaires)
  • Risk communication via labeling tools (e.g., Summary of Product Characteristics, Patient Information Leaflets)
• + Aggregate Reports
  • Preparation of Periodic Safety Update Reports (PSURs) and Annual Safety Reports (ASRs)
• + Signal Management
  • Detection of new safety signals from ICSR databases, literature, FDA monitoring, and aggregated sources
  • Risk minimization recommendations and development of Signal Management Trackers and Annual Signal Reports
• + Local PV Contact (Philippines)
  • Acting as the Local Pharmacovigilance Contact in the Philippines (as required by the FDA Philippines)
  • Serving as the official liaison with the Philippines FDA Pharmacovigilance section for all safety-related communications
  • Ensuring 24/7 availability for urgent regulatory queries and safety alerts
  • Supporting periodic reconciliation, compliance reporting, and local literature screening
  • Assisting in pharmacovigilance inspections and maintaining country-level PV documentation
• + Other PV Services
  • Authoring and review of PSMF and PV SOPs
  • Monthly reconciliation and compliance reporting
  • Quarterly signal surveillance meetings and medical reviews
  • Oversight of PV Quality Management Systems
  • PV Audit & Compliance: mock audits, gap assessments, staff training, and inspection readiness