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 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 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 new advisory statements for labels of over the counter (OTC) medicines containing triptans (sumatriptan, zolmitriptan, rizatriptan, eletriptan) , for inclusion in the Required...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
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
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
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
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
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
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
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
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
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
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
The Australian Government has a clear and bold vision for sport integrity in Australia, and is committed to ensuring Australian sport is appropriately protected in the rapidly evolving sports integrity threat environment .
The reforms announced as part of this package will require...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...More
On 14 August 2020, the Hon Mark Coulton, Minister for Regional Health, Regional Communications and Local Government, announced a review into the Hearing Services Program.
An Independent Expert Panel comprising Professor Mike Woods (Chair) and Dr Zena Burgess is conducting the Review. The...More
The Therapeutic Goods Administration (TGA) is seeking feedback on options to improve the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The Code is the compliance standard that prescribes the minimum requirements for the lawful advertising of therapeutic goods to the general...More
Health services funded under the Indigenous Australians’ Health Programme (IAHP) collect and supply important Indigenous health data sets to the Department of Health as part of their funding agreements. These are the:
Aboriginal and Torres Strait Islander National Key Performance...More
Scheduling amendments referred to expert advisory committee
This 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 June 2021 meeting of the ...More
From 25 February 2021, a new framework for regulating software as a medical device will commence. The Regulation of software based medical devices details these changes, and additionally the following guidance documents have also been published to assist users understand the various...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications to amend the Poisons Standard in relation to substances used in oral contraceptives. The scheduling proposals, and any submissions received, will be considered at the June 2021...More
CONTENT WARNING
The Department of Health acknowledges the devastating effects associated with acts of self-harm on individuals, their families, friends and communities. This consultation relates to information on self-poisonings that some people may find distressing. If you, or someone you...More