TGA Releases Compliance Principles for 2026-2027 Enforcement

TGA Australia Media Releases

Published January 22nd, 2026

Detected March 12th, 2026

Summary

The Therapeutic Goods Administration (TGA) has released its compliance principles for 2026-2027, outlining a refreshed, proactive, and risk-based approach to enforcement for therapeutic goods in Australia. The principles apply across all TGA-regulated areas and will be reviewed every two years.

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What changed

The Therapeutic Goods Administration (TGA) has published its compliance principles for 2026 and 2027, detailing a strategic shift towards a more proactive and risk-based enforcement model for therapeutic goods in Australia. This updated approach, which follows a review of previous priorities, will guide the TGA's monitoring and enforcement activities across all regulated sectors, including medicines and medical devices, with a focus on emerging risks, misinformation, and online sales. The principles are designed to be agile and responsive, ensuring compliance and enforcement efforts protect public health.

Regulated entities, including drug manufacturers, medical device makers, and pharmaceutical companies, should familiarize themselves with these new principles and understand how they will shape the TGA's enforcement activities over the next two years. While no specific compliance deadlines are mentioned, the TGA emphasizes a risk-based approach, suggesting that entities should proactively ensure compliance with all relevant regulations to avoid potential enforcement actions. The principles will be reviewed again in late 2027.

What to do next

Review the TGA Compliance Principles 2026 and 2027 document.
Assess current compliance strategies against the new proactive and risk-based enforcement approach.
Monitor for any specific focus areas or emerging risks identified by the TGA for the 2026-2027 period.

Source document (simplified)

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

Published

22 January 2026

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- LinkedIn
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The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for the import, export, manufacture, supply and advertising of therapeutic goods in Australia.

Following a review of the 2023-2025 Compliance Priorities, the TGA identified opportunities to strengthen how these priorities are set and reviewed. This includes changes to how often priority areas are assessed and how emerging risks are addressed.

The new approach applies across all TGA regulated areas, including medical devices, prescription and non-prescription medicines, complementary and listed medicines, unapproved therapeutic goods, and other therapeutic goods. This whole-of-sector approach ensures compliance and enforcement activities are strategic, collaborative, and responsive to emerging issues.

These changes reflect the TGA’s commitment to proactive and responsive regulation of therapeutic goods. They support ongoing collaboration with industry, healthcare professionals and consumers to promote voluntary compliance and, where necessary, take appropriate enforcement action to protect the public from harm.

Compliance and enforcement activities will be guided by 5 core principles and supported by regularly reviewed priority focus areas. The framework enables an agile response to emerging challenges and ensures a risk-based, rapid approach to high-impact issues, including those arising from misinformation, digital platforms and online purchases.

TGA’s compliance principles will be reviewed every 2 years to ensure they remain relevant and responsive to the dynamic regulatory environment, with the supporting focus areas enabling a responsive approach to compliance and enforcement efforts. The next review is scheduled for late 2027.

"Our 2026 and 2027 compliance principles and focus areas detail the how and why we act: to safeguard Australians from unsafe products, empower the community with clearer information, and take firm, proportionate action when the rules are broken or ignored,” said Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA.

TGA compliance principles

The TGA’s compliance principles from 1 January 2026 to 31 December 2027 are:

Safeguarding therapeutic goods
Educate to empower
Protect those most at risk
Leverage digital capability
Strengthen enforcement Urgent compliance issues will continue to be addressed as they arise, ensuring public health protection remains paramount.

TGA priority focus areas to 31 March 2026

The TGA’s compliance and enforcement activities are currently focused on 12 key areas:

Direct to consumer in vitro diagnostic (IVD) kits
Erectile dysfunction medications
Foetal dopplers
Listed medicine advertising
Medicinal cannabis
Melatonin
Software as a medical device
Substandard and falsified therapeutic goods
Sunscreen
Weight loss medications
Therapeutic goods used in cosmetic procedures
Vaping goods. Priority focus areas will be reviewed quarterly and updated as required via intelligence-led and risk-based reviews of emerging or continued risks to public health and safety.

Our compliance principles and focus areas should be read alongside our Regulatory Compliance Framework, which describes our approach to compliance, including how we encourage voluntary compliance and respond to alleged contraventions of the law.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices or suspected non-compliant advertising on the TGA website.

Contact for members of the media: