Articles

A two-day blitz on the sale of illegal vaping goods in Hobart and surrounds has resulted in seizures across 5 retail businesses for the alleged unlawful possession of commercial quantities of vaping goods and illegal tobacco.

Adoption of International Scientific Guidelines

We have published a list of medical devices in the ARTG that incorporate artificial intelligence (AI) or machine learning (ML) technologies.

Know how we manage compliance of AI and software products that meet the definition of a medical device.

We have issued 3 infringement notices totalling $59,400, to Victorian-based companies for the alleged unlawful advertising of therapeutic goods, in contravention of the Therapeutic Goods Act 1989.

From 1 September 2025, the TGA will adopt an updated version of the PIC/S Guide to GMP (PE009-17), with changes focused on Annex 1 for sterile medicines, and a phased compliance approach for manufacturers.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has launched a public consultation on proposed revisions to its ‘Guide to GMP for Medicinal Products’.

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

The TGA has issued a direction notice to Dispensed Pty Ltd to cease advertising of medicinal cannabis on all websites, social media accounts or other advertising platforms.

We are currently investigating the CHOICE report on sunscreen SPF, as per our previous statement on 19 June 2025. This update recognises the significant public interest in this matter.

The Prescription Medicines in Pregnancy database has now been updated to include the following new entries:

The GMP Clearance SID now contains additional data as well as progress information on the Compliance Verification (CV) backlog reduction strategy.

We have published information to clarify when digital scribes - also referred to as AI scribes or ambient scribes - are regulated as medical devices in Australia.

The TGA, assisted by Victoria Police, seized illicit vapes worth approximately $40,000 from a retail outlet in a highly prominent location in Melbourne’s CBD.

There has been an increase in the illegal advertising and online sales of nicotine pouches, with many of these products being imported from overseas.

We will be conducting a public consultation to gather information from stakeholders on their knowledge, experiences and observations of the use of unapproved medicinal cannabis products in Australia.

We initiated targeted compliance reviews of selected listed medicines containing Vitamin D to verify whether sponsors had appropriate evidence to support their bone strength claims.

The TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).

We have published our Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report.

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

The TGA has facilitated the seizure of millions of counterfeit and illegal therapeutic goods as part of a global initiative targeting illegal trade.

Information on the completion of automatic extensions for Good Manufacturing Practice (GMP) clearances and next steps.

The TGA suggests extra safety measures for some sunscreen ingredients but advises Australians to keep using sunscreen. Public consultation will determine safe levels.

Following a number of stakeholder queries, the TGA is providing an updated statement on the PFAS ban. The original statement was published on 27 June 2025.

In 2025, the Therapeutic Goods (Exempt Monographs) Amendment Determination was introduced under the Therapeutic Goods Act 1989. This amendment updates the 2021 determination to exempt specific labelling requirements in certain pharmacopoeial monographs.