Although Australia and New Zealand are geographically close-to the point mistakenly considered to be one country-their pharmacovigilance (PV) systems are governed by different frameworks and guidelines. This article highlights the most important aspects of each system.

Pharmacovigilance Framework – Australia

In Australia, pharmacovigilance is governed primarily by the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.

Guidance is provided in the TGA’s document Pharmacovigilance responsibilities of medicine sponsors (Version 3.0, published August 2023, fully effective from February 2024, with further updates noted in late 2024). This aligns with EMA GVP Module VI but is specifically adapted for the Australian context.

For any drug to be legally marketed in Australia, an Australian sponsor must be responsible for it. The medicine must be included in the ARTG (Australian Register of Therapeutic Goods), and a pharmacovigilance system must be established and maintained.

Key Legal Provisions

Therapeutic Goods Act 1989

• Section 28(5)(ca) – requires sponsors to keep records related to the reporting of adverse effects.
• Section 29AA – outlines requirements for notifying adverse events and safety issues.
• Section 31(1) – empowers the TGA to request information from sponsors within specified timeframes.

Therapeutic Goods Regulations 1990

• Regulation 15A – prescribes adverse event reporting obligations for sponsors.

Guideline

• The TGA’s guidance document (Pharmacovigilance responsibilities of medicine sponsors V3.0) explains how sponsors must comply with the Act and Regulations.
• Compliance is monitored through the Pharmacovigilance Inspection Program (PVIP), which checks if sponsors meet these legal requirements in practice.

Summary of TGA Guidance Document

The guidance outlines mandatory (must) requirements versus guidelines for sponsors of ARTG-listed or registered medicines. This aligns with EMA GVP Module VI but is specifically harmonized for Australia.

This applies to all ARTG-listed or registered medicines, regardless of marketing status. It excludes unapproved medicines supplied under clinical trials, the Special Access Scheme, or the Authorized Prescriber Scheme.

Sponsor ‘Must’ Responsibilities

These legal obligations apply to all sponsors:

– Appoint an Australian PV Contact Person (A-PVCP) within 15 days of ARTG entry or updates.

– Submit Serious Adverse Reaction (SAR) reports regardless of marketing status within 15 days for local and overseas cases, and keep a record of non-serious cases.

– Notify Significant Safety Issues (SSIs) within 72 hours and Other Safety Issues (OSIs) within 30 days.

– An SSI is any new or validated safety concern that may change the known benefit–risk balance of a medicine and require immediate regulatory action.

– Maintain PV records as per the Therapeutic Goods Act 1989, for at least 10 years after the medicine has been removed from the ARTG.

– Respond to TGA requests within statutory timeframes. The default legal timeframe is 10 working days, but the TGA may set a different deadline depending on the type of correspondence.

– Operate an effective PV system covering all outsourced or shared arrangements.

Reporting Summary Table

Signal Management & Analysis

Sponsors should critically analyze safety data, identify signals, and assess causality. Verified signals that alter benefit–risk must be reported as SSIs with proposed actions.

Oversight via TGA Inspections (PVIP)

The Pharmacovigilance Inspection Program (PVIP) evaluates compliance. Scope includes:

– Adverse reaction management
– Signal detection
– Safety information updates
– Adequacy of A-PVCP/QPPVA roles
– Third-party PV agreements
– Quality Management Systems
– Risk Management Plan (RMP) adherence and PSURs

Inspections are usually announced 6–8 weeks in advance, though unannounced inspections can occur. Post-inspection, CAPA plans must be implemented.

PV System Framework (Guideline)

Pharmacovigilance Framework – New Zealand

Key Legal Provisions

– Medicines Act 1981 (Section 41 – duty to report substantial untoward effects).
– Privacy Act 2020 and Official Information Act 1982.
– Therapeutic Products Act 2023 (to replace Medicines Act by 1 September 2026).

Guideline

– Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ), Part 8: Pharmacovigilance, Edition 3.0 (March 2024, effective 1 July 2024).
– It also draws on the European Medicines Agency (EMA) Good Pharmacovigilance Practice (GVP) guidelines as international best practice.
– Published by Medsafe, Ministry of Health.

Key Requirements

– Nominate a local PV contact person (preferably in NZ or reachable during business hours), notify within 15 days of approval or change.

– Report Serious ADRs occurring in NZ within 15 calendar days.

– Notify Significant Safety Issues (SSIs) within 72 hours.

– Notify Other Safety Issues (OSIs) within 30 days.

– Submit ICSRs via CIOMS I form (webform, email, or EFT). Direct E2B transmission planned.

– Perform literature reviews at least every 3 months.

– Manage signals in line with EMA GVP Module IX.

– Oversight by Medsafe with support from the Centre for Adverse Reactions Monitoring (CARM).

PV System Framework (Guideline)

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