Articles

How to find information about the inactive ingredients in your medicines.

Xofluza approved as part of an international work-sharing initiative between the TGA, Health Canada and Swissmedic

Measles vaccine testing shows the vaccine meets required standards

Acalabrutinib receives approval through the second international collaborative review initiative between the TGA, FDA and Health Canada

General information for consumers on prescription opioids

Japan has recently been added to the list of Foreign Countries and Jurisdictions determined to be comparable overseas regulators

International Collaborative Review Initiative gives provisional approval of lenvatinib in combination with pembrolizumab

The Federal Court has imposed substantial penalties on Peptide Clinics Australia

The prescription medicines regulatory reforms include changes that will bring medicines to market sooner in Australia, while maintaining a robust framework for safety, quality and efficacy.

Cabozantinib (CABOMETYX) is the first medicine to be registered via the new COR-A pathway

Apalutamide (Erlyand) is the first medicine approved via ACSS Consortium’s NCE working group

s23 instruments supporting the new COR process have been updated.

The TGA begins piloting electronic submissions for registered medicines using the eCTD format, supported by updated software and a revised Module 1 aligned with European standards.