Public consultation on the interim decision to amend the Poisons Standard in relation to adrenaline - ACMS, June 2025

Interim decision on proposed amendments to the Poisons Standard in relation to adrenaline. This consultation is for an interim decision made in relation to adrenaline that was discussed at the JUNE 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) . Kindly note...

Closes 12 January 2026

Public consultation on interim decisions to amend the Poisons Standard - ACCS & Joint ACMS-ACCS - MARCH, 2025

Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the March 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee...

Closes 23 January 2026

Adoption of International Scientific Guidelines in Australia R01-2025

The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted. Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external consultation...

Closes 10 February 2026

Digital Mental Health Tools User Survey

The number of people using software, including artificial intelligence (AI), to diagnose, manage and treat mental health conditions is growing. Apps, websites, and computer programs designed for these purposes are referred to as digital mental health tools. The Therapeutic Goods Administration...

Closes 11 February 2026

Digital Mental Health Tools Regulatory Environment Survey

There is growing interest in using software and artificial intelligence (AI) in healthcare delivery, including where it is used to support people with mental health conditions. The Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to software-based medical devices –...

Closes 11 February 2026

Consultation on proposed changes to labelling of medicines supplied in Australia

Medicine labels give health professionals and consumers important information to help use medicines safely and correctly. If labels are hard to read or understand, medication errors are more likely. Medicines prescribed or given by a health professional have different risks and need...

Closes 24 February 2026

NOTIFICATION FORM: Clinical decision support software exemption

This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 . The exemption applies to medical devices that are clinical decision...

Closes 25 December 2031

Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR

Transitioning devices This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. Complete this form if you are a sponsor or agent seeking to...

Closes 31 July 2029

Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR

This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. This tool will assist you to determine what actions you may or may not need to take...

Closes 31 July 2029