Articles

Delays in processing timeframes of applications to extend GMP Clearances.

The Prescribing Medicines in Pregnancy database has now been updated.

The TGA has issued 5 infringement notices to 3 health practitioners for the alleged unlawful importation of unregistered prescription-only medicines.

New warnings for baricitinib, tofacitinib and upadacitinib follow a TGA review of a randomised safety trial called the ORAL Surveillance Study.

The TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination

The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).

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

Medicines Safety Update - Information for health professionals

From 1 June 2023, prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists.

The TGA has published a final decision to reduce the maximum size of packs for various paracetamol products.

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.

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

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

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989

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.