Articles

Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) have been made resulting in compounded GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients.

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.  

Annex 16 will apply to therapeutic goods manufactured from 3 September 2024. Find out about the transition period.

Find out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, which commenced on 14 June 2024.

This instrument is the Therapeutic Goods (Poisons Standard) (Benzylpenicillin—Seqirus) Approval 2024.

We are reviewing the safety information supporting notifications of the highest-risk medical devices used in first-in-human clinical trials. Find out how the changes we have implemented impact you as a sponsor. 

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.

One of the key functions of the Therapeutic Goods Administration (TGA) is to closely monitor the safety of therapeutic goods. But to properly monitor safety, we need everyone to report any side effects and problems they have.

Some online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.

An infringement notice of $18,780 has been issued to Myers Pharmacy Pty Ltd for the alleged unlawful advertising of Ozempic, a prescription-only medicine.

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.

Medicines Safety Update - Information for health professionals

The Product Information documents for antidepressants have been updated with warnings about sexual dysfunction continuing in some patients, after they stop using the medicines.

The Dolphins National Rugby League club has worked with us, agreeing to remove Alternaleaf branding from its jerseys and on signages displayed at stadiums during its games.

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.

Consistent with recent EMA updates of acceptable intakes for established N-nitrosamines, the TGA has published updated acceptable intakes for nitrosamines in medicines.

Be aware that cannabis oil or cannabis flower medicine coming from overseas, or here in Australia, both must comply with the quality standard. Products that don't, may be unsafe.

We will adopt the 2021 Sunscreen Standard into therapeutic goods legislation. If you're a manufacturer or sponsor, find out what this means for you.

It is alleged the companies unlawfully advertised medicinal cannabis using terms including ‘medical cannabis’ and ‘plant medicine’, allowing patients to purchase prescription-only medicines after online consultation.

Medicines Safety Update - Information for health professionals

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 Assessed listed medicine evidence guidelines have been updated, based on feedback, to aid sponsors in preparing their product applications.

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