Articles

On 14 December 2018, the TGA issued an infringement notice for export of unlawful medicines from Australia

Reforms relating to accessing unapproved products include modifications to the Special Access Scheme and Authorised Prescriber scheme to allow streamlined access to certain unapproved therapeutic products.

The complementary medicine regulatory reforms include changes that will create a new approval pathway for listed complementary medicines and increase availability of information to support consumer decisions.

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.

Reforms to TGA advisory committees include changes that provide greater efficiencies and a reduction in the number of statutory advisory committees that provide independent advice to the TGA.

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

List of OTC codeine-containing products moving to prescription only

Information to help sponsors understand the provisional approval pathway for prescription medicines.

The codeine re-scheduling RIS and associated economic modelling report are now available

This response presents a strategic and systems-based approach to achieve long-term sustainable reform

Current funding arrangements to end on 31 March 2016

An overview of the process for determining the most effective composition for the annual influenza virus

The Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM). 

The TGA is advising consumers against purchasing or using black salve, red salve or cansema products.