Increasing transparency of Good Manufacturing Practice (GMP) inspection outcomes

The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to publish information about Good Manufacturing Practice (GMP) compliance on the TGA website. The purpose of publishing this information is to: improve transparency of regulatory oversight of...

Closes 13 July 2026

Public consultation on interim decision to amend the Poisons Standard in relation to psilocybine - ACMS JUNE 2025

Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for the interim decision made in relation to psilocybine that was discussed at the June 2025 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . Kindly note that the...

Closes 31 July 2026

ODC Medicinal Cannabis Permit Holder Supply Pathways 2026

The Office of Drug Control (ODC) is seeking feedback from permit holders under the Narcotic Drugs Act 1967 on supply pathways used by industry participants. Your feedback will help the ODC better understand current industry practices and identify opportunities to develop practical...

Closes 31 July 2026

Proposed changes to the Permissible Indications Determination

Proposed changes to the Permissible Indications Determination Listed medicines are considered low-risk medicines as they can only use low-risk ingredients and make low-level indications. These medicines are not individually evaluated by the Therapeutic Goods Administration (TGA) before they...

Closes 12 August 2026

Improvements to the Therapeutic Goods Advertising Code

The Therapeutic Goods Administration (TGA) within the Department of Health, Disability and Ageing is seeking feedback on options and proposed changes to improve the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code). We are reviewing parts of the Code to...

Closes 3 September 2026

Form: Confirmation of M2M HL7 SPL testing completion

This form is for medical device sponsors, manufacturers, or agents. It lets you advise the Therapeutic Goods Administration (TGA) that you confirm that your organisation has completed M2M HL7 SPL testing in accordance with the validation procedure in the M2M HL7 SPL – User Guide – AusUDID...

Closes 1 January 2100

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