Articles

Risk of Guillain-Barre syndrome added to Product Information.

Updated illustrations clarify how to use measuring syringe for oral solutions.

While we encourage health practitioners to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.
In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks.

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

Updated information for nitrosamine impurities in medicines consistent with recent EMA updated information.

The dual labelling period for some medicine ingredients is ending on 30 April 2025.

We are seeking applications from professionals with relevant expertise in medicine and science, and consumers with relevant expertise in consumer perspectives and issues.

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.

Updates further highlight potential risks of mood-related changes and sexual disorders.

Update on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.

The Prescription Medicines in Pregnancy database has now been updated to include the following new entries:

Listed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.

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

Listed medicine compliance review reports database March 2025 update

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This instrument is made under subsection 7C(1) of the Therapeutic Goods Act 1989.

The updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies.

The Therapeutic Goods Administration (TGA) has seized more than 5,000 vapes, 7,000 nicotine pouches and other products across two locations in Sydney’s western suburb of Penrith.

More prominent warnings are being added to the product information (PI) and consumer medicine information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects

There may be an increased risk of neurodevelopmental disorders in children born to men who have taken sodium valproate in the 3 months before conception.

Following a request from the sponsor to reconsider their decision, the TGA has confirmed the initial decision to not register the medicine on the basis that the safety and efficacy of the medicine were not satisfactorily established.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2025, which commenced on 1 March 2025