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Pharmacovigilance Services in New Zealand

Medsafe (Medicines and Medical Devices Safety Authority) supervises the ADR (Adverse Drug Reaction) reporting for medicines and medical devices. Medsafe operates under the Medicines Act 1981 which mandates sponsors to report substantial untoward effects of their medicines. Anyone including the public, health professionals, and the therapeutic goods industry, can report ADRs to the Centre for Adverse Reactions Monitoring (CARM) online or by phone, post, fax, and email. Medsafe assesses the causality of suspected ADRs, whether confirmed or not. Reporting is voluntary for clinicians and the public but mandatory for sponsors of both registered and listed drugs.

Medsafe focuses on adverse events related to new drugs, drug or vaccine interactions, unlisted suspected adverse events, and serious events such as death, hospitalization, or congenital defects. The CARM database maintains information on adverse events in New Zealand. Challenges for Medsafe include underreporting of side effects and lack of comorbidity data, which can hinder identifying factors contributing to adverse events.

Why Choose DDReg for Pharmacovigilance Services in New Zealand?

DDReg combines local expertise with global standards to deliver superior pharmacovigilance services. Our commitment to safety and regulatory excellence ensures that your products remain safe and compliant in the New Zealand market.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR Processing & tracking sheets
  • Reconciliation process with customers
    • ", h32: "Risk Management Plan

  • Drafting, reviewing, and maintaining 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 and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification 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)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

Qualified Person/Qualified Person for Pharmacovigilance (QPPV)/(QP)

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV and Deputy
  • Local Safety Responsible
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight

PV Audit & Compliance

  • Review Audit and Compliance to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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Call us on:+1 (302) 601-2755