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

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.

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

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.

An update about expected increases in the number of medical device incident reports reported to the TGA

We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 51 listed medicines

Temporary risk-based strategies to expedite the reduction of the GMP Clearance Compliance Verification (CV) backlog commences today.

Our second online study is open now.

Medical devices, including components in the device, primary packaging, instructions for use, and spare parts, will not be affected by the PFAS ban.

Learn about the strengthened standards for all therapeutic vaping goods for smoking cessation and nicotine dependence.

This statement is an update to provide technical clarification regarding information on laboratory testing and release of information by the TGA. The original statement was published on 12 June 2025.

We are aware of a CHOICE report where a number of sunscreens were found to not meet their claimed Sun Protection Factor (SPF) ratings.

Temporary risk-based strategies are being introduced to expedite the reduction of the Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) backlog.

Following a public consultation process , the TGA has adopted the following 19 international scientific guidelines.

Our Good Manufacturing Practice (GMP) Clearance information resources have been updated with new information for Sponsors

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