Articles

There is growing interest in using software and artificial intelligence (AI) in healthcare settings, including where it is used to support people with mental health conditions.

The GMP Guidelines on Chapter 1 - Pharmaceutical Quality System are being updated to reflect contemporary Quality Risk Management principles and further improve how Product Quality reviews are performed.

We have received 2 serious adverse event cases in neonates in which EMLA (topical prilocaine/lidocaine cream) was applied for a circumcision procedure. Both cases were likely to have involved overdose.

This Legislation Amendment makes changes to the way testing of goods is conducted under the Therapeutic Goods Regulations 1990.

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 18 listed medicines

There has been an increase in Australians purchasing melatonin products from online stores, particularly for use in children. These products are often sold as gummies but are also available as tablets or capsules marketed as dietary supplements.

Results of our investigation into the safety and efficacy of Vyvanse.

We initiated targeted compliance reviews of selected listed medicines containing Lysine Hydrochloride to verify whether sponsors had appropriate evidence to support their cold sore-related claims.

On 23 September 2025 the TGA made the decision to approve the registration of the lecanemab (LEQEMBI).

A review of the GMP Clearance backlog reduction strategies that have been implemented and ongoing monitoring and reporting communication.

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

As per our previous statement on 21 August 2025, the TGA is currently investigating a CHOICE report on Sunscreen SPF testing. This update provides information for consumers.

The TGA is currently investigating the CHOICE report on Sunscreen SPF testing, as per our previous statement on 21 August 2025. This update outlines the steps that sunscreen sponsors should take if they identify a problem with their product.

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.

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.

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.

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.