TGA Compliance Principles 2026-2027 – What is the TGA’s current focus?

by Katarina Klaric, Principal, Stephens Lawyers & Consultants

In Australia the manufacture, import, export, supply and advertising of therapeutic goods (including prescription and non-prescription medicines, complementary and listed medicines, medical devices and unapproved therapeutic goods) is regulated by the Therapeutic Goods Administration (“TGA”). The TGA works closely with Australian Border Force and the Federal, State and Territory Police in relation to the interception, seizure and destruction of illegal, unregistered or counterfeit products.

The TGA has released its “TGA Compliance Principles for 2026 and 2027”[i]. The principles provide guidance in relation to compliance activities and priority focus areas of the TGA. Businesses operating in these areas should undertake internal compliance reviews to ensure that they are compliant with the Therapeutic Goods Act and regulations including the Therapeutic Goods Advertising Code.

TGA current priority focus areas

The TGA’s current priority compliance and enforcement activities are focused on:

Direct to consumer 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 medication
Therapeutic goods used in cosmetic procedures
Vaping goods.

The priority focus areas will be reviewed and updated on a quarterly basis to reflect the emerging and ongoing risks to public health and safety having regard to data and intelligence from TGA regulatory compliance activities.

In addition to these areas, the TGA may take compliance and enforcement action in relation to any other areas of non-compliance detected or reported to the TGA. The TGA’s other compliance programs continue to operate and these programs include:

Compliance activities associated with complementary medicine listings
Monitoring and vigilance of medical device inclusions (medical devices and post-market reviews)
Pharmacovigilance and good clinical inspection programs
Good Manufacturing Practice (GMP) compliance program
Software and AI medical device compliance.

TGA Compliance Principles 2026 and 2027

The TGA’s compliance framework for the next two years reflects the TGA’s recognition that its approach to compliance and enforcement activities must be agile with a risk-based focus responding to emerging challenges arising from advertising and misinformation on social media and other digital platforms and on-line purchases.

The five TGA compliance principles are:-

Safeguarding Therapeutic Goods

This ensures protection from unsafe products and provide visibility to the public in relation to action taken. The TGA will proactively scrutinise advertising on websites and social media and take enforcement action to disrupt the supply of unapproved and falsified goods, including those sold via e-commerce and social media.

TGA Warning – Counterfeit weight loss products claiming to contain GLP-1[ii]

TGA issued safety warning and advisory notices on 29 September 2025 and 2 March 2026 in relation to the importation and on-line advertising of GLP-1 products for weight loss in Australia. The products were being promoted as ‘GLP-1 peptide’ oral drops or liquids and product labels claimed that the products contained GLP-1 or GLP-1 analogues. GLP-1 receptor agonists (like semaglutide, tizepatide, liraglutide) are prescription-only medicines in Australia and require registration on the Australian Register of Therapeutic Goods (ARTG).

TGA laboratory testing of several imported unregistered products confirmed that the products contain no GLP-1 or any GLP-1 analogues. The products’ labels falsely claimed to contain glucagon-like peptide-1 (GLP-1) receptor agonists or GLP-1 analogues, when this was not the case, posing a potential health risk to consumers.

The products tested by the TGA are considered counterfeit under the Therapeutic Goods Act 1989 and are not included in the ARTG.

The TGA warned consumers to only buy prescription medicines from a registered pharmacy and not to buy unregistered GLP-1 products through social media or other digital platforms.

Educate to Empower

The TGA will proactively engage with the public, industry and other stakeholders through guidance, education and other mechanisms to provide accessible education for consumers, health professionals and industry, and to counter online misinformation and disinformation including social media and influencer content.

Protect Those Most at Risk

The TGA will engage and collaborate with community leaders to develop appropriate content and targeted strategies for the most vulnerable and at-risk communities and to achieve compliance.

Leverage Digital Capabilities

The TGA will provide an active response to the rising digital and technological risks by modernising and enhancing the tools that it uses to monitor online activities and to address risks from AI-generated misinformation and deceptive endorsements of products.

Strengthen Enforcement

The TGA will be strengthening its enforcement capabilities and activities to provide and re-enforce public and industry confidence by taking swift and proportionate action, responding to emerging trends including targeting non-compliance via digital channel, including influencers and on-line marketplaces. The TGA will also be increasing its visibility of compliance actions.

TGA compliance and enforcement actions

The TGA determines on a case-by-case basis, the type of compliance and enforcement action it takes having regard to the nature of the breach and safety issues. The Therapeutic Goods Act provides the TGA wide powers to address non-compliance and unlawful advertising and supply of therapeutic goods including counterfeit goods. The range of compliance and enforcement actions that may be taken by the TGA include- warning notices, Section 45AB Notices under the Therapeutic Goods Act, infringement notices, search and seizure warrants, infringement notices, suspension or cancellation of ARTG registrations, product recalls, court proceedings for injunctions and imposition of penalties and criminal prosecutions[iii].

Authored by Katarina Klaric, Principal, Stephens Lawyers & Consultants

© Stephens Lawyers & Consultants. 22 March, 2026

This update is not intended to be a substitute for obtaining legal advice.

For further information contact:

Katarina Klaric

Principal

Stephens Lawyers & Consultants

Melbourne Head Office

Level 40, 140 William Street, Melbourne VIC 3000

Phone: (03) 8636 9100; Fax: (03) 8636 9199

Sydney Office

Level 29, Chifley Tower, 2 Chifley Square, Sydney, N.S.W. 2000
Phone: (02) 9238 8028