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The TGA has approved applications submitted by Australian Red Cross Lifeblood (Lifeblood) to remove most of the sexual activity ineligibility criteria for plasma donors used for fractionated products only. Lifeblood refers to this approach as ‘the plasma pathway’.

It is alleged that the individual attempted to import six different types of nicotine vaping products (prescription medicines). The unapproved nicotine vaping products were intercepted by the Australian Border Force and have been seized and will be destroyed under advice from the TGA.

Transition period for accepting ISO 13485 ends 26 May 2023.

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

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

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

The Prescribing Medicines in Pregnancy database has now been updated.

Delays in processing timeframes of applications to extend GMP Clearances.

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).

Medicines Safety Update - Information for health professionals

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

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

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.

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.