The Australian Medical Research and Innovation Strategy (Strategy) is determined by the Australian Medical Research Advisory Board (AMRAB). The current Strategy covers the period 2016-2021, with the next Strategy (2021-2026) to be registered before 8 November 2021. The Medical Research...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed new advisory statements for labels of over the counter (OTC) medicines containing triptans (sumatriptan, zolmitriptan, rizatriptan, eletriptan) , for inclusion in the Required...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed advisory statements for labels of over the counter (OTC) medicines containing mometasone in dermal and nasal spray preparations , for inclusion in the Required Advisory Statements...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed advisory statements for labels of over the counter (OTC) medicines containing melatonin, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) . The proposal to include...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed minor changes to advisory statement requirements for labels of over the counter (OTC) medicines containing chlorhexidine, hydrocortisone or ibuprofen , for inclusion in the ...More
The Department of Health has commissioned an independent review of general practice accreditation arrangements.
The purpose of this consultation is to seek stakeholder feedback on the strengths and limitations of general practice accreditation and its intersection with educational...More
Scheduling amendments referred to expert advisory committee
This pre-meeting consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the November 2021...More
It is important that patients have access to information about their implanted medical devices.
Globally, the requirements for medical device patient information materials vary. Implementation of requirements for these materials in Europe is occurring now through to 2024, whilst in...More
Published in 2000, Australia’s National Medicines Policy (NMP) aims to deliver positive health outcomes for all Australians through their access to and appropriate use of medicines. It is a well-established and universally endorsed framework based on partnerships between consumers and all...More
Scheduling amendments referred to expert advisory committee
This consultation is for an interim decision made in relation to an application to amend the Poisons Standard, following advice sought at the 17-18 March 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and...More
The Therapeutic Goods (Excluded Goods) Determination 2018 provides that “household and personal aids, or furniture and utensils, for people with disabilities” are excluded goods, and so regulated as consumer products rather than therapeutic goods.
This exclusion of aids for...More
From 25 February 2021, a new framework for regulating personalised medical devices will commence. Comprehensive guidance about the framework can be found at: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices
The Therapeutic Goods...More
This form should be used by manufacturers and sponsors of medical devices that record patient images or that are anatomical models, and that will be reclassified by the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for...More
Please note this form closes at 11.59pm on 24 August 2021
This form should be used by sponsors and manufacturers of software-based medical devices that will need to be included in the ARTG at a higher classification as a result of the amendments to the Therapeutic Goods (Medical Devices)...More
The Department of Health invites submissions in relation to proposed improvements to the Private Health Insurance (PHI) Prostheses List (PL). Consultation paper 1 concerns to the purpose, definitions and scope of the Prostheses List.
In the 2021-22 Federal Budget, the Australian...More
As part of the TGA Digital Transformation, the public search of the Australian Register of Therapeutic Goods (ARTG) is under review so we can better meet your needs. The ARTG is a register of therapeutic goods that can be lawfully supplied in Australia.
We welcome your feedback on 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 17-18 March 2021 meetings of the Advisory Committee on...More
There are currently three medicines available for the treatment of opioid dependence under the Pharmaceutical Benefits Scheme (PBS) Opiate Dependence Treatment Program (ODTP). These medicines are buprenorphine (tablets and modified release injections), buprenorphine with naloxone (films) and...More
In early 2019 the Therapeutic Goods Administration (TGA) conducted a public consultation seeking feedback on a proposal to introduce new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied...More
On 1 March 2021 the Government announced that it would review and enhance the Aged Care Quality Standards in response to a recommendation made by the Royal Commission into Aged Care Quality and Safety. To inform this review, the department has engaged KPMG to undertake an evaluation of the...More
The Serious Incident Response Scheme for residential aged care commenced on 1 April 2021. The SIRS sets new arrangements for residential aged care providers, including flexible care in a residential setting, to manage and take reasonable steps to prevent incidents, with a focus on the safety,...More
ATTENTION: Due to difficulties many of our stakeholders are experiencing in lockdown, the closing date for submissions to this consultation has been extended until Wednesday 29th September 2021 . The outcomes of the consultation will now be anticipated for publication on Wednesday 15th...More
Healthy Food Partnership
Portion sizes of many foods are increasing in Australia (1). In late 2015, the Australian Government established the Healthy Food Partnership (HFP) with the aim of improving the dietary habits of Australians by making healthier food choices easier and more...More
On 11 May 2021, the Australian Government announced changes to the Commonwealth Home Support Programme (CHSP) to help position the aged care sector as it moves towards a new support at home program commencing in July 2023. The new program will replace the CHSP, Home Care Packages, Short-Term...More
The National Key Performance Indicators for Aboriginal and Torres Strait Islander primary health care (nKPIs) collects information from organisations that are funded under the Indigenous Australians’ Health Programme to provide primary health care services to Aboriginal and Torres Strait...More
On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are designed and manufactured for individual patients (otherwise known as 'personalised'...More
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.
We are seeking feedback to make sure the...More
The Efficient Funding of Chemotherapy (EFC) Program provides funding for chemotherapy medicines used for the treatment of cancer that are administered through infusion or injection at public or private hospitals. Not all chemotherapy medicines are provided through the EFC Program, but may be...More