Articles

Approval of the Therapeutic Goods

Approval of the manner of making requests under subsection 9D(3) of the Therapeutic Goods Act 1989 to vary the entry in the Australian Register of Therapeutic Goods of registered therapeutic goods

Consultation on low value turnover exemption (LVT) scheme

The amendments made to the Therapeutic Goods Act 1989 (the Act) by the Therapeutic Goods Amendment (2013 Measures No. 1) Act 2014 commenced on 28 February 2014.

The TGA reviewed studies on tartrazine, a yellow colouring used in medicines, and found it safe when properly labelled, with no strong evidence of harm like allergies or behavioural issues.

The TGA and Medsafe have developed a common list of colouring substances allowed in medicines for oral and topical use.

New Zealand changes paediatric dosage instructions for paracetamol and ibuprofen to align with Australia.

Pilot web service for transmission of adverse event reports from medical software to the Therapeutic Goods Administration

Medical Devices Safety Update, Volume 2, Number 1, January 2014

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

Medicines Safety Update, Volume 4, Number 4, August 2013

THERAPEUTIC GOODS ACT 1989

Undertaking to the Secretary of the Australian Department of Health and Ageing given for the purposes of section 42YL of the Act

Mifepristone and misoprostol can be prescribed in Australia by registered medical practitioners.

Hospital supply departments, health professionals, carers and users should check that male urinal bottles are free of sharp edges, both inside and outside the bottle. Any cracks, chips or sharp edges may injure users.

The TGA Prescription Medicines Streamlined Submissions Process Newsletter [formerly the Prescription medicine BPR update (BPR update)] reports on progress of the streamlined submission process.

Safety advice for health professionals on preventing accidental disconnections of patient lines and medical devices, reducing risk of harm.

The Prescription medicine BPR update (BPR update) reports on progress of the streamlined submission process. Each quarter, an update is provided on the PI/CMI project and the AusPAR project.

The Australian government will introduce a comprehensive package of reforms for Australia's Therapeutic Goods Administration (TGA) to ensure the regulation of medicines and medical devices is more effective and transparent.

The TGA intends to cancel all pain-killers containing dextropropoxyphene - Capadex, Di-Gesic, Doloxene and Paradex - from the Australian Register of Therapeutic Goods (ARTG), from 1 March 2012.

The Australian Customs and Border Protection Service and the Therapeutic Goods Administration have taken part in an international ‘Week of Action’ targeting the online sale of counterfeit and illegal medicines.

Contrary to media reports today, the TGA has not approved the use of Nembutal by Dr Nitschke.

The TGA's Incident Reporting and Investigation Scheme receives reports about the safety and performance of medical devices as part of its ongoing monitoring of products supplied in Australia. As part of this process the TGA has recently reviewed several reports associated with repaired endoscopes. These reports relate to the quality of the repair and the use of unsuitable parts.

The Australian Government today released the report of the Therapeutic Goods Administration (TGA) Transparency Review panel, chaired by Professor Dennis Pearce.