Browse TGA consultations below, or search for consultations by keyword, interest or status. Once finalised, decisions will be published under closed consultations.
The Government is now operating in accordance with the Caretaker Conventions pending the outcome of the 2022 federal election.
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of some spinal implantable medical devices. from Class IIb (medium-high risk) to Class III (high risk), effective from 25...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of medical devices that administer medicines or biologicals by inhalation to Class IIa (low-medium risk) or Class IIb (medium-high...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of all surgically invasive medical devices intended to be used in direct contact with the heart, central circulatory system (CCS)...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019, to include the reclassification of medical devices composed of substances that are intended to be introduced into the human body through a body orifice or applied...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of active implantable medical devices (AIMD) from Class AIMD to Class III (high risk), effective from 25 November 2021.
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Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications to amend the Poisons Standard, following advice sought at the 3-4 November 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the ...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23-25 June 2020 meetings of the Advisory Committee on...More
Prescription medicines have been used ‘off-label’ for a given indication for many years to treat conditions or uses that have not been registered in Australia. Whilst this is often aligned with accepted clinical practice, it can lead to patient inequity as it is applied in an ad hoc manner at...More
The Therapeutic Goods Administration (TGA) is seeking feedback on the updated ‘Listed medicines evidence guidelines – How to demonstrate efficacy for listed medicines’ (the Guidelines), which is intended to replace the existing ‘ Evidence guidelines – Guidelines on the evidence...More
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals .
The proposed 'Priority Review' pathway will align with the pathway in place for medicines and offer a faster formal assessment pathway...More