Additional public consultation on the scheduling of ethylene oxide, propylene oxide and epichlorohydrin

Proposed scheduling amendments for ethylene oxide, propylene oxide and epichlorohydrin This consultation is in relation to a proposal to amend the current scheduling of ethylene oxide, propylene oxide and epichlorohydrin. All the three substances are listed is the current Poisons...

Closes today

Public Consultation - TGA fees and charges proposal 2027-28

Consultation: Fees and Charges Proposal 2027-28 The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on the TGA’s proposed fees and charges for the 2027-28 financial year....

Closes 16 November 2026

Consultation: Clinical Trials Schemes Improved Information Sharing

The Therapeutic Goods Administration (TGA) is seeking feedback on new approaches to information sharing under the clinical trial schemes. We propose to strengthen the TGA’s ability to release and publish information relevant to the oversight of clinical trials. These proposals are intended...

Closes 20 November 2026

Consultation: Proposed TGA comments to Annex 2 of ICH E6(R3) Guideline for Good Clinical Practice (GCP)

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed TGA comments to Annex 2 of the ICH E6(R3) Guideline for Good Clinical Practice (ICH GCP E6(R3)). TGA comments explain Australian-specific considerations that should be taken into account when applying the guideline. ...

Closes 20 November 2026

High-moderate risk changes to permissible ingredients – Vitamin B6 (pyridoxine hydrochloride, pyridoxal 5-phosphate, and pyridoxal 5-phosphate monohydrate)

The Therapeutic Goods Administration (TGA) is seeking public comment on proposed changes to the Therapeutic Goods (Permissible Ingredients) Determination (the Permissible Ingredients Determination) relating to listed medicines containing vitamin B6, namely pyridoxine hydrochloride, pyridoxal...

Closes 25 November 2026

Consultation: Reviewing the exclusion for certain digital mental health tools

We want your feedback on options for the future regulation of certain digital mental health tools (DMHTs). Digital mental health tools (DMHTs) include apps, websites and chatbots that provide assessment, therapy or self-management strategies for mental health conditions. They are playing...

Closes 7 December 2026

Notification form: Lapses in medical device conformity assessment certification

Please use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). Conformity assessment certification may lapse due to the certification expiring, or if it has been suspended or revoked. Notifying the...

Closes 31 July 2035

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