The pharmacovigilance regulatory environment shifted meaningfully in 2025. For Australian sponsors operating domestically or across multiple jurisdictions, the year delivered substantive changes to reporting frameworks, signal management responsibilities, and AI governance expectations. Rather than incremental refinements, several regulators introduced structural reforms that reshape how pharmacovigilance systems operate.
This analysis examines the twenty most consequential updates from a practitioner perspective. The focus is practical: what changed, what it means for operations, and what evidence your system needs to demonstrate.
TGA Advances GVP Module Adoption
Australia’s Therapeutic Goods Administration moved decisively on international harmonisation in 2025. On 13 March, the TGA adopted GVP Module VI (Rev 2) covering adverse reaction reporting processes. This was followed on 9 September by GVP Module I, which addressed pharmacovigilance system quality—a foundational standard that has guided European operations since 2012.
These adoptions carry real operational weight. While not legally mandated, TGA inspectors increasingly reference GVP modules when assessing sponsor systems. Australian sponsors maintaining alignment with European parent companies will find documentation expectations now formally consistent. However, organisations must still apply Australian-specific requirements where TGA guidance diverges from EU references—particularly around data protection obligations under the Privacy Act 1988.
What Auditors Look For:
- Quality system documentation aligned with Module I principles
- SOP coverage matching Module VI adverse reaction handling requirements
- Clear reconciliation where Australian requirements differ from EU references
Medical Device Adverse Event Reporting Framework
Australia became one of the first jurisdictions worldwide to mandate hospital-level reporting of medical device adverse events. The framework operates in two phases:
For device sponsors, this creates new data streams requiring integration into existing vigilance systems. Hospital liaison arrangements and case reconciliation procedures need to be established before mandatory reporting begins.
TGA Inspection Trends Show Improvement
The TGA’s 2022-2024 inspection data reveals targeted progress. Average deficiencies decreased from 6.9 to 6.7 per inspection, with major deficiency rates improving from 2.7 to 1.8. Quality Management System major deficiencies dropped from 3 to 0. Case management remains a focus area, though improvement trajectories suggest the industry is responding to prior feedback.
These figures matter for resource planning. Sponsors with mature QMS implementations experience shorter inspection durations and fewer remediation requirements.
EU Regulation 2025/1466: The Most Significant EU Change Since 2012
The European Commission’s Regulation 2025/1466, published 23 July 2025, represents the most substantial pharmacovigilance regulatory change in the EU since the original 2012 framework. Entry into force occurred on 12 August 2025, with full compliance required by 12 February 2026.
Key operational impacts include:
- EudraVigilance monitoring obligation: All EEA Marketing Authorisation Holders must now monitor EudraVigilance data for signals as a mandatory source alongside other databases
- Signal validation shift: EMA and national competent authorities now validate EudraVigilance signals—MAHs identify but no longer validate
- Third-party oversight: Subcontracted PV activities require comprehensive contracts covering roles, audit rights, and a prohibition on further subcontracting without written consent
- PSMF streamlining: Only major or critical deviations require documentation until resolved
- Enhanced PSURs: Reports must include risk minimisation measure implementation and effectiveness updates
For Australian sponsors with EU-authorised products, contract reviews with European PV service providers are immediately warranted. The third-party oversight provisions address recurring inspection findings and create new audit obligations.
EMA Compliance Notifications and GVP Publications
Starting September 2025, EMA rolled out automated monthly compliance notifications for ICSR reporting timelines via EudraVigilance. These notifications enforce 7/15/90-day deadlines and include non-compliant case listings with performance metrics. The initial rollout covered the top 20 MAHs and all NCAs, with full rollout by December.
Additionally, two GVP guidelines were published in 2025: guidance on pregnant and breastfeeding populations and an addendum on risk minimisation for embryo-fetal risks. Module VI Addendum II (effective 25 July 2025) provides detailed guidance on personal data masking for ICSRs submitted to EudraVigilance—operationalising GDPR requirements within pharmacovigilance.
FDA Real-Time FAERS Publication
On 21 August 2025, FDA Commissioner Marty Makary announced daily publication of adverse event data from FAERS, replacing quarterly reporting. This fundamentally shifts safety signal communication—healthcare professionals, industry, and the public now access emerging signals in near real-time.
Australian sponsors monitoring US-market products need procedures to address more frequent FAERS reviews. Signal detection intervals may require adjustment, and communication protocols should anticipate faster public awareness of emerging safety concerns.
FDA AI Guidance: Credibility Assessment Framework
The FDA’s January 2025 draft guidance on AI for regulatory decision-making establishes a seven-step credibility assessment framework. While not PV-specific, it applies to AI models producing information supporting safety determinations. The framework emphasises context of use definition, data quality, and representativeness, performance with uncertainty quantification, robustness, and lifecycle monitoring.
For PV operations considering AI-assisted case processing or signal detection, this guidance provides validation expectations. The emphasis on “final determinations” requiring heightened scrutiny aligns with maintaining human oversight in safety-critical decisions.
FDA REMS Program Eliminations
The FDA eliminated two historically restrictive REMS programs in 2025:
- Clozapine REMS (13 June 2025): Removed mandatory registry requirements while maintaining blood monitoring
- CAR T Cell Therapy REMS (26 June 2025): Eliminated certification requirements based on accumulated safety data
These decisions reflect regulatory confidence built through post-market surveillance. They demonstrate how robust pharmacovigilance data enables proportionate risk management evolution.
MHRA Windsor Framework Implementation
- From 1 January 2025, MHRA restructured UK medicines regulation into two categories with different PV obligations:
- Category 1 (Former EU Centralised products): UK-wide licences following UK PV requirements only
- Category 2 (Non-centralised products): Dual compliance with UK and EU requirements
- Category 2 products create significant operational complexity—parallel PSUR submissions with different data lock points, separate RMPs requiring version control, and dual regulatory engagement. Sponsors with products previously authorised only in Great Britain may face retrospective remediation if EU reporting capabilities were not previously established.
Health Canada Risk Management Plan Guidance
Health Canada’s updated RMP guidance, effective 1 July 2025, replaces the 2015 requirements. The guidance reflects Agile Regulations elements while anticipating complete RMP regulatory requirements from April 2027. Canadian sponsors should conduct gap analyses against the new expectations before the 2027 deadline.
China GVP Enforcement Intensification
China’s GVP regulations, introduced in 2021, are now subject to strict enforcement, with substantial penalties for non-compliance. NMPA is increasing inspections of drug safety monitoring systems, particularly for biologics, cell therapies, and imported drugs. International sponsors with Chinese market products should verify local PV system adequacy and inspection readiness.
AI in Pharmacovigilance: Regulatory Reality Assessment
The 2025 AI regulatory landscape for pharmacovigilance requires careful interpretation. Industry narratives sometimes overstate how prescriptive current requirements are.
The practical conclusion: PV teams should operationalise validation, human oversight, governance, and bias mitigation now rather than waiting for prescriptive AI-in-PV regulations. The EU AI Act’s high-risk classification will likely capture many safety databases and signal detection tools.
Implementation Checklist: Priority Actions
For Australian sponsors managing multi-jurisdictional obligations, these actions warrant immediate attention:
- Review EU PV service provider contracts against Regulation 2025/1466 third-party requirements.
- Establish EudraVigilance monitoring procedures if not already integrated into signal detection.
- Assess Category 2 UK product exposure and dual compliance capability.
- Update SOPs referencing newly adopted TGA GVP modules.
- Prepare hospital liaison arrangements for mandatory device-adverse-event reporting.
- Document an AI governance framework for any ML/AI tools in PV operations.
- Adjust FAERS review intervals for a real-time publication environment.
Why This Matters for Your Organisation
These regulatory changes share a common theme: increased expectations for documented oversight, traceable decision-making, and proactive risk management. The shift toward mandatory EudraVigilance monitoring, stricter vendor audit requirements, and AI governance frameworks reflects regulators’ focus on system quality rather than just individual case handling.
For Australian sponsors, the TGA’s GVP module adoptions signal continued alignment with international standards. Organisations maintaining separate “Australian” and “international” approaches face growing documentation burdens—harmonised systems become operationally advantageous.
Practical Next Steps
- Regulatory change requires a systematic response. Start with gap analysis: compare current procedures against the specific requirements outlined above. Prioritise by implementation timeline—EU Regulation 2025/1466 provisions requiring February 2026 compliance warrant immediate attention, while Health Canada’s 2027 RMP deadline allows longer planning horizons.
- For multi-jurisdictional operations, map products to their regulatory category combinations. UK Category 2 products with EU and Australian registrations are the most complex, requiring coordinated updates to procedures across regions.
- Finally, document your AI approach now. Whether you use AI tools in case processing, literature surveillance, or signal detection, create governance documentation addressing validation, human oversight, and performance monitoring. When regulators issue more specific guidance, you’ll adapt existing frameworks rather than building from scratch.
- The 2025 regulatory developments reward proactive preparation. Sponsors demonstrating mature, documented systems—whether in traditional PV processes or AI-enabled workflows—face inspections with confidence rather than concern.
FAQ Section
References:
- TGA Guideline on Good Pharmacovigilance Practices (GVP) Module VI – Collection, Management, and Submission of Reports of Suspected Adverse Reactions to Medicinal Products (Rev 2) https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-and-submission-reports-suspected-adverse-reactions-medicinal-products-rev-2
- TGA Guideline on Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/guideline-good-pharmacovigilance-practices-gvp-module-i-pharmacovigilance-systems-and-their-quality-systems
- TGA Obligations to Report Adverse Events for Medical Devices https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/obligations-report-adverse-event-medical-devices
- TGA Update from Pharmacovigilance Branch – ARCS 2025 Presentation https://www.tga.gov.au/sites/default/files/2025-06/b13-update-from-pharmacovigilance-branch-arcs-2025-presentation.pdf
- EUR-Lex Commission Implementing Regulation (EU) 2025/1466 https://eur-lex.europa.eu/eli/reg_impl/2025/1466/oj/eng
- EMA Compliance Notifications Explanation Q&A https://www.ema.europa.eu/en/documents/other/compliance-notifications-explanation-qa_en.pdf
- EMA Good Pharmacovigilance Practices (GVP) Guidelines https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp
- EMA Highlights of 20th EMA-Industry Platform Meeting https://www.ema.europa.eu/en/documents/report/highlights-20th-ema-industry-platform-meeting-operation-eu-pharmacovigilance-legislation-meeting_en.pdf
- EMA Q&A on Implementing Regulation (EU) 2025/1466 – Signal Detection and EudraVigilance https://www.ema.europa.eu/en/documents/other/questions-answers-implementing-regulation-eu-2025-1466-amendment-regulation-eu-no-520-2012-conclusion-signal-detection-eudravigilance-pilot-marketing-authorisation-holders_en.pdf
- FDA Press Announcement – FDA Begins Real-Time Reporting of Adverse Event Data https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data
- FDA Draft Guidance – Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological
- FDA Information on Clozapine (REMS Elimination) https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-clozapine
- FDA Eliminates REMS for Autologous CAR T Cell Therapies https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
- FDA Press Announcement – FDA Launches Crackdown on Deceptive Drug Advertising https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising
- FDA Draft Guidance – Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postapproval-methods-capture-safety-and-efficacy-data-cell-and-gene-therapy-products
- MHRA Windsor Framework and Medicines Regulation Guidance https://www.gov.uk/government/collections/mhra-windsor-framework#full-publication-update-history
- Health Canada – New Agile Regulatory Provisions and Updated Guidance Document for Submitting Risk Management Plans https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/new-agile-regulatory-provisions-updated-guidance-document-submitting-risk-management-plans-notice.html
- Health Canada – Consultation on Guidance Document Updates for Good Pharmacovigilance Practices (GVP) Inspections https://www.canada.ca/en/health-canada/programs/consultation-guidance-document-updates-good-pharmacovigilance-practices-gvp-inspections.html
- EUR-Lex – EU Artificial Intelligence Act (Regulation 2024/1689) https://eur-lex.europa.eu/eli/reg/2024/1689/oj
- EMA News – EMA Welcomes Political Agreement on New EU Pharmaceutical Legislation https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation
- TGA Pharmacovigilance Responsibilities of Medicine Sponsors https://www.tga.gov.au/resources/guidance/pharmacovigilance-responsibilities-medicine-sponsors
- EMA Third Annual Report on Real-World Evidence (RWE) Use https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence
Disclaimer
This article is provided for educational and informational purposes only. It is intended to support general understanding of regulatory concepts and good practice and does not constitute legal, regulatory, or professional advice.
Regulatory requirements, inspection expectations, and system obligations may vary based on jurisdiction, study design, technology, and organisational context. As such, the information presented here should not be relied upon as a substitute for project-specific assessment, validation, or regulatory decision-making.
For guidance tailored to your organisation, systems, or clinical programme, we recommend speaking directly with us or engaging another suitably qualified subject matter expert (SME) to assess your specific needs and risk profile.
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