At the recent ARCS PV Summit 2025, one message was abundantly clear: PV non-compliance is not just a process issue-it could be a legal liability.
Key Takeaways from the Summit
🔹 The TGA is set to increase the frequency of pharmacovigilance inspections, including the potential for re-inspections based on previous compliance findings. The ultimate goal is to drive stronger sponsor compliance and continuous improvement in medicine safety oversight.
🔹 Sponsors hold the legal responsibility for PV compliance, regardless of whether activities are outsourced to third parties. Therefore, both sponsors and their partners must ensure that roles, responsibilities, and processes are clearly defined, documented, and executed in alignment with current regulatory expectations.
🔹 Sponsors of all medicine types are equally obligated to meet pharmacovigilance requirements. However, the TGA has indicated a sharpened focus on listed medicines as a priority area in its 2025 inspection program.
🔹 Recent critical findings highlight serious gaps, including:
– Lack of a local PV system
– A-PVCPs details not up date
– Inadequate system and processes to collect adverse events
– No centralised safety data access in Australia
Financial and legal consequences
The TGA has issued significant fines, in some cases up to $100,800, for various forms of regulatory non-compliance. Pharmacovigilance-related issues, such as missing safety contact details, have featured among the cited breaches, while other sponsors have been subject to enforceable undertakings.
Is Your Organization Inspection-Ready?
At Commercial Eyes, we help sponsors build and maintain robust pharmacovigilance systems through:
✅ Inspection readiness support
✅ Mock audits, gap assessments & CAPA management
✅ Comprehensive PV agreements
Ensuring your organisation is prepared for the TGA’s evolving inspection landscape is not just a regulatory necessity, it’s a commitment to patient safety, brand integrity, and public trust.
Contact us today to discuss how we can support your compliance efforts and help you confidently
navigate the complexities of pharmacovigilance.
Lorenza Ricacho
Regional Head of Patient Safety
Lorenza has been with Commercial Eyes since 2011 and leads our Patient Safety and Risk Management team supporting our clients from the pharmaceutical, medical devices, generics & OTC, cosmetics sectors...
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