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

We have introduced new features to improve your experience using Guidance on our website.

TGA has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease).

SAHPRA and TGA have signed a Memorandum of Understanding which will strengthen collaboration between the two health product regulators.

We have issued an infringement notice to the New South Wales based company for the alleged supply of a complementary medicine that was missing a mandatory warning statement.

This instrument is made under regulations 10AC, 10FA and 10HA of the Therapeutic Goods Regulations 1990.

This instrument is made under regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.

We are advising sponsors of updates to the Generic Medicines Work-Sharing Initiative (GMWSI) operational procedures.

The TGA reminds businesses and media outlets that it is unlawful to publicly advertise prescription-only medicines, including prescription-only weight loss medicines.

Following an extensive internal and external consultation process, we have adopted the following 13 international scientific guidelines.

Infringement notices were issued to businesses and individuals for the alleged unlawful advertising of prescription-only medicines on their websites.

TGA has issued 3 infringement notices totalling $56,340 to News Life Media Pty Ltd for alleged unlawful advertising of medicinal cannabis on their popular lifestyle website Body+Soul.

We have accepted an enforceable undertaking from 2San Pty Ltd in relation to breaches of the Therapeutic Goods Act 1989. This relates to the company's unlawful import and supply of medical devices.

The company imported medical devices not included in the Australian Register of Therapeutic Goods. They supplied these devices to a national retailer, who then sold them to the public.

Find out about regulatory changes to a range of medical devices and application audit requirements.

TGA has issued 35 infringement notices totalling $627,252 to 6 businesses and 2 individuals for the alleged unlawful advertising of medicinal cannabis on their websites and social media platforms.

The Bill is part of reforms to prevent and reduce the use of vapes in Australia, unless clinically appropriate for stopping smoking or the management of nicotine dependence.  

The director of Elite Labs Pty Ltd was sentenced to 2 years imprisonment for his role in the unlawful manufacture, supply, advertising and export of performance and image enhancing therapeutic goods.

Infringement notices totalling $171,972 have been issued to Better Leaf Pty Ltd, and an individual, for the alleged unlawful advertising of medicinal cannabis on its website and social media.

We have issued 2 infringement notices totalling $37,560 to Global Medical Solutions Australia Pty Limited, trading as Radpharm Scientific Pty Ltd, for allegedly breaching conditions of its manufacturing licence

Victoria-based nurse has been issued 2 infringement notices totalling $7,512 for allegedly importing unapproved prescription-only and cosmetic injectable products.

An individual based in Victoria has been fined $3,756 for the alleged unlawful importation of a peptide. They did not have approval to import the prescription-only medicine.

TGA officers executed a search warrant on a Sydney residence linked to an individual suspected of being involved in the manufacture and sale of compounded semaglutide.

The second phase of the Recall Reforms Program is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining public safety.