Articles

The granting of a provisional determination means that the TGA has made a decision that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods.

Updated safety advisory - rare and unusual blood clotting syndrome (thrombosis with thrombocytopenia)

Updated storage conditions for the Pfizer COVID-19 vaccine

TGA has recently approved wider storage and transportation conditions for the Pfizer COVID-19 vaccine in Australia

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

The TGA is investigating the advertising of stem cell therapies to ensure that content in the public domain complies with the Australian rules for advertising therapeutic goods.

The Scheduling Delegate has decided to seek further advice in relation to psilocybin and MDMA

Some rare cases of thrombosis associated with thrombocytopenia have been reported overseas following the administration of COVID-19 Vaccine AstraZeneca.

Australia’s vaccine safety and regulatory process is world class and people can be confident that vaccines approved for use are safe and effective.

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

New legislative instrument

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.

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

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

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

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.

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

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.

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