The Therapeutic Goods Administration (TGA) has released its compliance principles for 2026 and 2027, reinforcing a proactive, risk-based approach to regulation, monitoring, and enforcement of therapeutic goods in Australia. These principles reflect a commitment to safeguarding public health, encouraging voluntary compliance, and taking proportionate enforcement action where necessary. The updated framework applies across all TGA-regulated areas, including prescription and non-prescription medicines, medical devices, complementary and listed medicines, unapproved therapeutic goods, and emerging products such as software as a medical device.

Strategic Approach to Compliance and Enforcement

The TGA’s refreshed compliance principles build upon a review of the 2023–2025 compliance priorities, identifying opportunities to improve how these priorities are set, reviewed, and applied. The new approach is designed to be agile, responsive, and risk-based, ensuring that enforcement activities focus on areas of highest potential impact. By taking a whole-of-sector perspective, the TGA seeks to coordinate regulatory actions across therapeutic goods categories, ensuring that compliance monitoring, education, and enforcement are strategic, consistent, and effective.

The updated framework also recognises the growing importance of emerging risks, including digital platforms, online sales, and misinformation about therapeutic products. These challenges require a responsive regulatory approach that balances proactive oversight with the facilitation of legitimate innovation and access to safe therapeutic goods.

Five Core Compliance Principles

From 1 January 2026 to 31 December 2027, the TGA’s compliance activities will be guided by five core principles, which form the foundation of its regulatory approach:

Safeguarding Therapeutic Goods

The TGA prioritises public health by ensuring that therapeutic goods supplied in Australia meet safety, quality, and efficacy standards. This principle underpins all monitoring and enforcement actions, focusing on reducing harm to consumers, patients, and vulnerable populations. Safeguarding includes inspections, testing, and the monitoring of adverse event reports to identify products that fail to meet regulatory requirements.

Educate to Empower

The TGA recognises that education is a critical tool for promoting voluntary compliance. By providing clear guidance to manufacturers, suppliers, healthcare professionals, and consumers, the agency seeks to improve understanding of obligations, correct misperceptions, and empower stakeholders to make informed decisions regarding therapeutic goods. Educational initiatives complement enforcement by preventing unintentional non-compliance and supporting safer product use.

Protect Those Most at Risk

Certain populations are more susceptible to harm from unsafe or misleading therapeutic goods. This principle ensures that regulatory activities prioritise protecting vulnerable groups, including children, the elderly, and patients with complex health needs. By targeting enforcement and compliance measures where risk is highest, the TGA maximises public health protection.

Leverage Digital Capability

Digital technologies play an increasingly central role in therapeutic goods supply, communication, and monitoring. The TGA aims to harness digital capabilities to improve compliance oversight, including monitoring online advertising, tracking product distribution, and analysing adverse event data. By integrating technology, the agency can respond more rapidly to emerging risks and enhance transparency in regulatory activities.

Strengthen Enforcement

While voluntary compliance remains the first line of regulatory strategy, the TGA maintains the authority to take firm enforcement action when necessary. Strengthening enforcement ensures that entities who deliberately ignore or breach regulatory requirements are held accountable. Actions may include product recalls, sanctions, warnings, and prosecution where appropriate, reflecting a proportionate response aligned with public health protection objectives.

Priority Focus Areas to 31 March 2026

In addition to the overarching compliance principles, the TGA has identified 12 priority focus areas for early 2026. These areas represent therapeutic goods and practices that pose heightened risk to public health or are subject to emerging compliance challenges. The focus areas include:

• Direct-to-consumer in vitro diagnostic (IVD) kits

• Erectile dysfunction medications

• Foetal dopplers

• Listed medicine advertising

• Medicinal cannabis

• Melatonin products

• Software as a medical device

• Substandard and falsified therapeutic goods

• Sunscreen products

• Weight loss medications

• Therapeutic goods used in cosmetic procedures

• Vaping products

These priorities are reviewed quarterly, ensuring that enforcement activities remain intelligence-led and responsive to ongoing and emerging risks. By continuously assessing risk, the TGA ensures that limited regulatory resources are allocated where they will have the greatest impact on public health.

Integration with the Regulatory Compliance Framework

The TGA’s compliance principles should be understood in the context of its broader Regulatory Compliance Framework. This framework describes the agency’s approach to encouraging voluntary compliance, managing alleged contraventions, and taking proportionate enforcement action. It outlines the structured methodology for investigating non-compliance, assessing risk, and determining the appropriate response, from education and guidance to formal enforcement.

The integration of compliance principles with the Regulatory Compliance Framework ensures that all actions are evidence-based, proportionate, and consistent. It also provides transparency to industry, healthcare professionals, and the community regarding how and why regulatory actions are taken.

Addressing Urgent Compliance Issues

While the 12 focus areas provide strategic direction, the TGA retains the flexibility to respond to urgent compliance issues as they arise. Emerging threats to public health, including new substandard products, safety concerns, or widespread misinformation, are addressed promptly to prevent harm. This approach ensures that public health protection remains the agency’s top priority throughout 2026 and 2027.

Collaboration and Communication

The TGA emphasises collaboration with industry, healthcare professionals, and consumers. By maintaining open channels of communication and providing timely guidance, the agency promotes a culture of voluntary compliance. Engagement with stakeholders ensures that compliance activities are informed by real-world practices and that regulatory guidance remains practical, clear, and achievable.

Continuous Review and Adaptation

The compliance principles and focus areas are designed to be dynamic. The TGA conducts biennial reviews to ensure that the framework remains relevant and responsive to changes in the therapeutic goods sector. The next comprehensive review is scheduled for late 2027, allowing the agency to integrate lessons learned, emerging risks, and evolving regulatory requirements.

Conclusion

The TGA Compliance Principles for 2026 and 2027 reflect a proactive, risk-based approach to safeguarding public health through the regulation of therapeutic goods. By emphasising education, targeted enforcement, digital capability, and protection of vulnerable populations, the framework ensures that compliance activities are strategic, responsive, and effective. Combined with the Regulatory Compliance Framework and intelligence-led priority focus areas, these principles provide a robust foundation for consistent, transparent, and scientifically informed regulatory oversight. For therapeutic goods manufacturers, biotechnology companies, and testing laboratories, adherence to these principles is essential for maintaining compliance, protecting public health, and supporting safe and reliable access to therapeutic products.