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Joint statement from the TGA, Ahpra, Office of the Health Ombudsman and the Health Care Complaints Commission

The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

Conducting domestic inspections during the Coronavirus (COVID-19) pandemic

Ivermectin is a prescription medicine that is not approved in Australia (or in other OECD countries) to prevent or treat COVID-19 disease, and should not be imported for this indication.

On 20 August 2021 the TGA granted provisional determination to Roche Products Pty Ltd in relation to the combination therapy casirivimab + imdevimab (RONAPREVE)

On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare Australia Pty Ltd in relation to regdanvimab.

On 20 August 2021 the TGA granted provisional approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY).

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

The TGA has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine AstraZeneca to VAXZEVRIA.

The TGA has today approved for release doses of the Pfizer/BioNTech vaccine that arrived in Australia late last night from the Republic of Poland.

Users of nicotine vaping products are encouraged to make an appointment with their GP to discuss their smoking cessation options, ahead of changes from 1 October 2021.

On 9 August 2021 the TGA granted provisional determination to Merck Sharp & Dohme (Australia) Pty Ltd (MSD) in relation to Molnupiravir.

On 9 August 2021 the TGA granted provisional approval to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine, Spikevax (elasomeran), for individuals aged 18 years and over.

The Minamata Convention facilitates a global approach to address concerns relating to mercury, which is persistent, toxic and highly mobile in the environment once released, and recognised as a substance producing significant neurological and other effects in humans.

The TGA has issued twenty infringement notices totalling $266,400 to a Canberra-based dental practice.

The Federal Court of Australia has ordered Evolution Supplements Australia and its Director to pay $12 million

The TGA has issued four infringement notices totalling $10,656 to a Sydney-based individual, for alleged unlawful advertising of Cannabidiol Oil in breach of the Therapeutic Goods Act 1989.

PI used by healthcare professionals updated

The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.

This instrument is made under subregulations 4A.2(4) of the Therapeutic Goods (Medical Devices) Regulations 2002.

Joint ICMRA/WHO Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness.

The TGA has issued seven infringement notices totalling $93,240 to Melbourne-based global biopharmaceutical company Starpharma Holdings Limited (Starpharma), for alleged illegal advertising of a nasal spray that is not approved for use in Australia.

The TGA granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.