Articles

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.

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.

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.

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.

The GMP Clearance SID now contains additional data as well as progress information on the Compliance Verification (CV) backlog reduction strategy.

We have published information to clarify when digital scribes - also referred to as AI scribes or ambient scribes - are regulated as medical devices in Australia.

Information on the completion of automatic extensions for Good Manufacturing Practice (GMP) clearances and next steps.

Temporary risk-based strategies to expedite the reduction of the GMP Clearance Compliance Verification (CV) backlog commences today.

We have issued an infringement notice of $18,780 to Victorian-based company, Nourishmeorganics Pty Ltd, for the alleged unlawful supply of a therapeutic good not entered in the ARTG.

We have commenced proceedings in the Federal Court of Australia against Atlus and its sole director, Mamamia, News Life and Straight Up for advertising medicinal cannabis in alleged contravention of the Therapeutic Goods Act 1989.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2025, which commenced on 20 June 2025.

This statement is an update to provide technical clarification regarding information on laboratory testing and release of information by the TGA. The original statement was published on 12 June 2025.

We are aware of a CHOICE report where a number of sunscreens were found to not meet their claimed Sun Protection Factor (SPF) ratings.

The Therapeutic Goods Administration has commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited (PEAL) for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements.

Temporary risk-based strategies are being introduced to expedite the reduction of the Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) backlog.

Following a public consultation process , the TGA has adopted the following 19 international scientific guidelines.

Our Good Manufacturing Practice (GMP) Clearance information resources have been updated with new information for Sponsors

Complementary medicines are therapeutic goods that are often derived from traditional medicine practices. They can usually be purchased from supermarkets, health stores and pharmacies without seeing a doctor or pharmacist.
However, just because a medicine is available without a prescription, or claims to be ‘natural’ or ‘healthy’, doesn’t mean it’s safe for you.

We have issued 4 infringement notices totalling $75,120 to Queensland based pharmacy Summit Pharmacy Pty Ltd, for the alleged unlawful manufacturing of medicinal cannabis products.

We will be initiating targeted compliance reviews of selected listed medicines that are required to display a warning statement

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.