Articles

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.

We are conducting surveys to collect information about medical devices manufactured at the point-of-care.

The TGA has approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA has issued nine infringement notices to three companies and two associated individuals for the alleged unlawful importation of nicotine vaping products.

The TGA has approved the first commercially supplied test kit for the detection of Mpox (monkeypox) virus.

Find out about new transition arrangements for dual labelled ingredient names.

Information about the TGA's safety monitoring of COVID-19 vaccines.

From 1 July 2023, authorised psychiatrists can prescribe psychedelic medicines to people with specific mental health conditions under strict controls.

Essential Principle 7 now mentions nanomaterials explicitly (see EP 7.7).

Christopher Ramsey, the Director of AusLabs, Smart Labs and iSARMs, has been sentenced 2 years imprisonment and fined $300,000 for his role in the manufacture, supply and advertising of illegal Selective Androgen Receptor Modulators and nootropic products. Mr Ramsey’s three companies also received significant fines totalling $2,225,000.

Medicines Safety Update - Information for health professionals

From 22 March 2023 changes to the Therapeutic Goods Act 1989 will help alleviate the effects of medicine shortages on patients.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Provisional registration of Tecentriq (atezolizumab) for the treatment in mTNBC will lapse on 22 March 2023.

More applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.

Health professionals should check if patients undergoing general anaesthesia have used products containing pholcodine in the previous 12 months.

The TGA has issued an infringement notice for $13,320 to Sydney company JSHealth Vitamins Pty Ltd for an alleged breach of the Therapeutic Goods Act 1989.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA has issued 12 infringement notices totalling $159,840 to a manufacturer of listed complementary medicines after a recent inspection of the company’s premises identified unacceptable manufacturing practices.

On 22 February the TGA, with the assistance of NSW Police, executed 3 search warrants connected to an individual operating in the Newcastle area of New South Wales.

The TGA is aware of concerns about decreased effectiveness of monoclonal antibodies against the COVID-19 caused by emerging SAR-COV-2 variants. At this stage, the regulatory status of the products remain unchanged in Australia.

Medicines Safety Update - Information for health professionals

The TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.