Articles

Sunscreen SPF testing by AMA Laboratories - Regulatory update. Possible fraudulent testing of sunscreens and TGA efforts to mitigate effect on Australian consumers.

It is alleged the company breached the Therapeutic Goods Act 1989 in relation to the importation of surgical face masks.

A new standard, TGO 106, commences in January 2023 to provide clarity to sponsors serialising medicines or using data matrix codes.

TGA has issued two infringement notices for alleged unlawful advertising of a complementary medicine cancelled from the Australian Register of Therapeutic Goods.

TGA has issued four infringement notices for alleged unlawful advertising of a complementary medicine.

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

The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving the release of the first four batches.

TGA has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.

TGA issued a fine for alleged advertising of an unlisted complementary medicine after Junction Rx failed to comply with a cease and desist notice by the set deadline.

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

This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations

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

Access Consortium guidance for strain changes to COVID-19 vaccines

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

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

The TGA has issued two infringement notices to Perth-based company Bajaria Global Pty Ltd

Invitation to the National Measurement Institute's mask/respirator testing forum.

The TGA has issued four infringement notices for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads.

The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine

Federal Court finds Evolution Supplements Australia breached advertising laws

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

Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA)

Mr Leyonhjelm was directed to cease advertising a prescription medicine for the treatment of Covid-19.

The TGA has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.

Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 ceases on 31 January 2021.