Articles

An individual based in Victoria has been fined $3,756 for the alleged unlawful importation of a peptide. They did not have approval to import the prescription-only medicine.

Consistent with recent EMA updates of acceptable intakes for established N-nitrosamines, the TGA has published updated acceptable intakes for nitrosamines in medicines.

Voluntary cancellation of AstraZeneca COVID-19 vaccine: Vaxzevria

Be aware that cannabis oil or cannabis flower medicine coming from overseas, or here in Australia, both must comply with the quality standard. Products that don't, may be unsafe.

We will adopt the 2021 Sunscreen Standard into therapeutic goods legislation. If you're a manufacturer or sponsor, find out what this means for you.

It is alleged the companies unlawfully advertised medicinal cannabis using terms including ‘medical cannabis’ and ‘plant medicine’, allowing patients to purchase prescription-only medicines after online consultation.

Medicines Safety Update - Information for health professionals

Information about Real World Evidence (RWE) use in regulation of medicines and medical devices.

TGA officers executed a search warrant on a Sydney residence linked to an individual suspected of being involved in the manufacture and sale of compounded semaglutide.

The Assessed listed medicine evidence guidelines have been updated, based on feedback, to aid sponsors in preparing their product applications.

The second phase of the Recall Reforms Program is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining public safety.

The Minister for Health and Aged Care, the Hon Mark Butler MP, introduced a bill that aims to reduce the widespread availability of vapes by controlling all levels of the supply chain.

Our investigation into the risk of retinal vasculitis and/or retinal occlusive vasculitis in patients being treated with faricimab (Vabysmo) found that stronger warnings regarding this risk were needed in the Product Information (PI) and Consumer Medicine Information (CMI).

The Prescription Medicines in Pregnancy database has been updated to include new and amended entries.

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

Infringement notices for $82,500 have been issued to Caruso’s Natural Health Pty Ltd, for an alleged failure to hold information or evidence to support therapeutic uses in relation to medicines.

We have updated our guidance on advertising cosmetic injectables to ensure advertising rules are applied consistently across all industries that deal with therapeutic goods.

Find out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024.

From 3 June 2024, we will be using a new Good Manufacturing Practice (GMP) guide for medicines, active pharmaceutical ingredients and sunscreens.

The TGA and Health Canada have signed a Memorandum of Understanding to further increase collaboration and reliance on Good Manufacturing Practice inspections conducted in countries outside each other's borders.

Therapeutic goods and records have been seized from a pharmacy in Melbourne. This is part of our investigation into the alleged unlawful manufacture, supply and export of therapeutic goods.

The targeted consultation is part of a proposal to change the Therapeutic Goods Regulations 1990 to mitigate safety risks in the compounding of GLP-1 RAs.

The TGA has issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines

The TGA has issued 4 infringement notices totalling $75,120 to Liquefy Health Pty Ltd for the alleged unlawful importation and advertising of unapproved complementary medicines.

Medicines Safety Update - Information for health professionals