Articles

We have commenced proceedings in the Federal Court of Australia against Better Leaf Pty Ltd (Better Leaf), Better Life Aussie Pty Ltd (Better Life), and their sole director for the alleged unlawful advertising of medicinal cannabis.

We are reviewing new information that has raised concerns regarding the integrity and reliability of the clinical trial data that supported the approval of TAVNEOS (avacopan) in Australia.

TGA has issued an infringement notice, to the value of $19,800, to Cellife Health Care Pty Ltd (Cellife) for the alleged supply of a listed medicine that did not comply with an applicable standard, in contravention of the Therapeutic Goods Act 1989

Following a public consultation process between 24 November 2025 – 10 February 2026, the TGA has adopted 23 international scientific guidelines

We have added our recent decisions to the list of Australian manufacturers licensed by the TGA.

Product warnings across the glucagon-like-peptide-1 receptor agonist (GLP-1 RA) class of medicines have been updated due to the potential for these products to cause a rare, but severe, form of eye disorder.

Unapproved peptide products are being advertised as delivering fast health results, but they can pose serious health risks to consumers.

Information for health professionals about medicines with safety related updates to their Product Information.

New regulations are now in place across Australia to protect public health, by restricting access to nicotine pouches.

The TGA, in partnership with NT Health, Northern Territory Police Force and the Northern Territory Department of Trade, Business and Asian Relations, conducted a targeted multi-agency enforcement operation across three premises in Darwin.

TGA has released a new information page relating to the availability of s 9D(1) of the Act to correct information in the ARTG about listed medicines.

We have issued 5 infringement notices totalling $99,000 to Acacia Pharmacy Pty Ltd for the alleged unlawful importation of unapproved melatonin products, in contravention of the Therapeutic Goods Act 1989.

In March 2026, the Therapeutic Goods Administration (TGA) issued 3 infringement notices totalling $59,400 to Queensland-based company Canngea Pty Ltd.

We've launched a series of interactive e-learning modules designed to help stakeholders understand their regulatory obligations.

Cases of liver injury associated with herbal preparations containing Withania somnifera, commonly known as Ashwagandha, continue to be reported both in Australia and internationally.

We have issued 3 infringement notices totalling $11,880 to a nurse for the alleged unlawful importation of unapproved cosmetic injectables, which is illegal under the Therapeutic Goods Act 1989 (the Act).

From 1 July 2026, some medical devices supplied in Australia must meet Unique Device Identification (UDI) requirements.

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 13 listed medicines.

Australia’s health leaders are increasingly concerned about the growing availability, promotion and use of unapproved peptide products in Australia.

We have published new guidance on advertising restrictions for prescription medicines. This is to help individuals and businesses comply with Australia’s regulatory requirements.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026 .

We have issued 5 infringement notices totalling $19,800 to a health practitioner and an individual for the alleged unlawful importation of unapproved cosmetic injectables.

Information for health professionals about medicines with safety related updates to their Product Information.

Six monthly report – supply of unapproved therapeutic goods by a sponsor.

We have expanded our priority focus areas to include unapproved peptide products, following increased detection of unlawful importation, supply and advertising, posing potential risks to consumer safety.