Articles

While we encourage health practitioners to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.
In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks.

Updated information for nitrosamine impurities in medicines consistent with recent EMA updated information.

Information for health professionals about medicines with safety related updates to their Product Information.

Updates further highlight potential risks of mood-related changes and sexual disorders.

Update on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.

Information for health professionals about medicines with safety related updates to their Product Information.

More prominent warnings are being added to the Product Information (PI) and Consumer Medicine Information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects

There may be an increased risk of neurodevelopmental disorders in children born to men who have taken sodium valproate in the 3 months before conception.

Following a request from the sponsor to reconsider their decision, the TGA has confirmed the initial decision to not register the medicine on the basis that the safety and efficacy of the medicine were not satisfactorily established.

We are updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI)

Information for health professionals about medicines with safety related updates to their Product Information.

Australians who use tanning products containing ‘melanotan’ are at risk of serious health problems.

Information for health professionals about medicines with safety related updates to their Product Information.

Additional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events.

The defendant faces a maximum penalty of 12 months’ imprisonment and/or a fine of up to $222,000 for each charge.

Recall reforms program update and preview of the PRAC Version 1.0.

TCMs sold in Australia are carefully regulated to ensure safety and quality.

Information for health professionals about medicines with safety related updates to their Product Information.

If your business sells or advertises paracetamol, then you need to be aware of the new rules around pack sizes that commence on 1 February 2025.

Information for health professionals about medicines with safety related updates to their Product Information.

Health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.

We have received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination.

From 28 October 2024, Telstra and Optus are switching off their 3G networks. Medical devices and products like personal medical alarms could be affected by these closures.

Some medical device equipment could soon be affected as mobile network operators prepare to switch off their 3G networks.

Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.