Pharmacovigilance Services in Australia

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

The Therapeutic Goods Administration (TGA) is the national authority responsible for post-market safety surveillance of pharmaceuticals and medical devices in Australia. Clinical trials often do not capture all adverse drug reactions, especially rare ones. These might emerge only after the product is on the market. Under the Therapeutic Goods Act, the TGA is legally obligated to continuously collect, evaluate, and act upon safety information for approved or listed products. The pharmacovigilance framework ensures that patients, healthcare professionals, and other stakeholders are informed about risks and mitigation measures.

• Reporting of adverse drug reactions (ADRs) is overseen by TGA. Anyone – the public, general practitioners, nurses, other health professionals, and the therapeutic goods industry – can report ADRs via online systems, telephone, post, fax, or email. Whether or not the ADR is confirmed, TGA assesses causality.
• Reporting is voluntary for clinicians and the public; however, it is mandatory for sponsors of both registered and listed medicines under the Australian Register of Therapeutic Goods (ARTG) to report all suspected ADRs.
• TGA gives particular attention to serious or unexpected adverse events: those related to newly registered or listed drugs, drug-drug or vaccine interactions, events not listed in product information, and events involving death, hospitalization, or birth defects.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases and other relevant databases integrated with WHO Drug Dictionary and MedDRA
  • Quality check, medical review
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information; preparing reports recommending risk management services
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as academic materials, observational examinations, targeted follow-up questionnaires
  • Effectively conveying risks through labelling means such as Summary of Product Characteristics (SmPC) or Product Information, and Patient Information Leaflet (PIL)
• + Aggregate Reports
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals and/or changes in risk from ICSR databases, literature, aggregate reports, or regulatory agency website monitoring
  • Utilization of in-house tools and databases for signal detection and tracking
  • Safety signal review for ICSRs, aggregate reports, and recommendations by Pharmacovigilance Risk Assessment Committees
  • Label-update analysis
  • Recommendations from signal assessments including risk minimization approaches
  • Preparation of signal management trackers, annual signal reports
• + Australian Pharmacovigilance Contact Person
  • Review of PSMF, Safety Data Exchange Agreements (SDEAs), agreements with commercial partners, PV SOPs etc.
  • Review & sign-off of aggregate reports, signal reports, and RMPs
  • Retainer services for QPPV and deputy QPPV roles
  • Monthly reconciliation
  • Monthly communication reports / provision of compliance metrics
• + PV Quality Management System Oversight, Audit & Compliance
  • Review of compliance audits relative to applicable PV guidelines, regulations, SDEAs, SOPs and work instructions
  • Conduct regular gap assessments of PV staff at site locations
  • Optimise well-constructed audit plans and mock audits to prepare for PV inspections by the competent authority
  • Provide organisational training on safety audits and inspections