Articles

We have issued 10 infringement notices, totalling $198,000, to Midnight Health Pty Ltd (Midnight Health) for the alleged unlawful advertising of prescription-only weight-loss medicines.

We have accepted a court-enforceable undertaking from Midnight Health Pty Ltd in relation to the alleged unlawful advertising of prescription-only weight-loss medicines.

There has been an increase in Australians purchasing melatonin products from online stores, particularly for use in children. These products are often sold as gummies but are also available as tablets or capsules marketed as dietary supplements.

A blitz undertaken on Chapel Street retailers over two days this week has resulted in seizures of illegal vaping goods with a street value of over $40,000 and more than 24,000 nicotine pouches.

Results of our investigation into the safety and efficacy of Vyvanse.

We have issued 3 infringement notices totalling $11,268 to a Victorian-based individual for allegedly importing unapproved prescription-only medicines.

We initiated targeted compliance reviews of selected listed medicines containing Lysine Hydrochloride to verify whether sponsors had appropriate evidence to support their cold sore-related claims.

On 23 September 2025 the TGA made the decision to approve the registration of the lecanemab (LEQEMBI).

Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims.

A review of the GMP Clearance backlog reduction strategies that have been implemented and ongoing monitoring and reporting communication.

We have issued 6 infringement notices, totalling $118,800, and a direction notice to Dispensed Pty Ltd (Dispensed) for the alleged unlawful advertising of medicinal cannabis.

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

As per our previous statement on 21 August 2025, the TGA is currently investigating a CHOICE report on Sunscreen SPF testing. This update provides information for consumers.

The TGA is currently investigating the CHOICE report on Sunscreen SPF testing, as per our previous statement on 21 August 2025. This update outlines the steps that sunscreen sponsors should take if they identify a problem with their product.

Instructions for searching Australian manufacturers licensed for the manufacture of medicines, blood and biologicals.

A two-day blitz on the sale of illegal vaping goods in Hobart and surrounds has resulted in seizures across 5 retail businesses for the alleged unlawful possession of commercial quantities of vaping goods and illegal tobacco.

Adoption of International Scientific Guidelines

We have published a list of medical devices in the ARTG that incorporate artificial intelligence (AI) or machine learning (ML) technologies.

Know how we manage compliance of AI and software products that meet the definition of a medical device.

We have issued 3 infringement notices totalling $59,400, to Victorian-based companies for the alleged unlawful advertising of therapeutic goods, in contravention of the Therapeutic Goods Act 1989.

From 1 September 2025, the TGA will adopt an updated version of the PIC/S Guide to GMP (PE009-17), with changes focused on Annex 1 for sterile medicines, and a phased compliance approach for manufacturers.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has launched a public consultation on proposed revisions to its ‘Guide to GMP for Medicinal Products’.

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

The TGA has issued a direction notice to Dispensed Pty Ltd to cease advertising of medicinal cannabis on all websites, social media accounts or other advertising platforms.

We are currently investigating the CHOICE report on sunscreen SPF, as per our previous statement on 19 June 2025. This update recognises the significant public interest in this matter.