146 results
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Clarifying and strengthening the regulation of Artificial Intelligence (AI)
Artificial Intelligence (AI) has already made a difference to many lives, providing the potential to solve problems faster, and opening up opportunities to get things done in smarter and better ways. If safely deployed, its development and adoption can improve wellbeing, quality of life and economic growth. At the same time, caution is needed as AI presents a potential to create or amplify harms to individuals, organisations, communities and social cohesion through risks associated with its... MoreClosed 20 October 2024 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2024
Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the JUNE 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . Kindly note that the interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can be... MoreClosed 18 October 2024 -
Review of draft guidance - Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin
The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document ‘ Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin – Guidance on the new regulatory requirements and transition arrangements . ’ MoreClosed 9 October 2024 -
Form: Annual Reporting of Custom-made medical devices
Manufacturers and sponsors of custom-made medical devices must supply an annual report to the TGA, detailing all of the custom-made medical devices they have manufactured and/or supplied within the preceding 1 July - 30 June financial year. The report must be submitted by 1 October each year. The report to the TGA can be submitted using this form. Please note: This form is being hosted on a consultation platform, however it is not a consultation and information provided in the form... MoreClosed 1 October 2024 -
Consultation on temporary labelling exemptions for paracetamol
In May of 2023, t he delegate of the Secretary of the Department of Health and Aged Care made a final decision regarding paracetamol pack sizes in the Poisons Standard. Consultation To assist industry in transitioning to new requirements due to the upcoming changes to the scheduling of paracetamol, and to facilitate pharmacy’s ability to supply these products, we are proposing a period of labelling exemptions for signal words for certain... MoreClosed 30 September 2024 -
Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2024-25
The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination . The proposed changes address the following issues: Herbal ingredients with pregnancy contraindications and other toxic effects Garcinia species, hydroxycitric acid, hydroxycitrate complex and salts, and risk of liver injury Xanthium species ... MoreClosed 13 September 2024 -
Revision of the guidance document TGA Instructions for Disinfectant Testing
The Therapeutic Goods Administration (TGA) is seeking feedback on a revised version of the guidance document ‘TGA Instructions for Disinfectant Testing’. The TGA Instructions for Disinfectant Testing are a regulatory tool, used to provide guidance to sponsors and applicants as to what evidence must be held for their disinfectant/sterilant products to enable inclusion of their products on the Australian Register of Therapeutic Goods (ARTG). The document is used by members of... MoreClosed 30 August 2024 -
Reforming Australia's Therapeutic Goods Testing Regulations
The Therapeutic Goods Administration (TGA) is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance, and quality. We do this through the application of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and associated legislation. The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing... MoreClosed 28 August 2024 -
Consultation on the sunsetting Therapeutic Goods Order No.70C - Standards for Export Only Medicine
Therapeutic Goods Order No. TGO 70C (TGO 70C) – Standards for Export Only Medicine ( https://www.legislation.gov.au/F2014L00683/asmade/text ) is a relevant standard for therapeutic goods which are listed for export only in the Australian Register of Therapeutic Goods (ARTG). TGO 70C is due to sunset on 1 October 2024. The Therapeutic Goods Administration (TGA) Export Unit as part of the Prescription Medicines Authorisation Branch (PMAB) is reviewing the sunsetting TGO with the intention... MoreClosed 26 August 2024 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS MARCH, 2024
Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the MARCH 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) and Joint ACMS-ACCS. The closing date for this consultation is close of business 23 AUGUST 2024. All submissions received by the deadline will be considered by... MoreClosed 23 August 2024 -
Consultation: Legislating regulatory categories for some boundary and combination products
The Australian Government is undertaking significant reforms to further improve regulation of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA) is the government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals. Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated... MoreClosed 20 August 2024 -
Consultation on a proposed exposure model for assessing the safety of sunscreen ingredients in Australia
The Therapeutic Goods Administration (TGA) is seeking public comment on proposed models to estimate sunscreen use (exposure) by Australians which will be used to calculate the maximum safe concentration of sunscreen ingredients. The options proposed for stakeholder consideration include: Option 1: Australian Sunscreen Exposure Model (ASEM) The ASEM calculates the highest estimated daily sunscreen exposure, by integrating expected sunscreen... MoreClosed 13 August 2024 -
Updates to Australian medicine labelling rules to support medicine safety
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed changes to the rules for Australian medicine labels. We want to make sure that certain information important to health professionals is displayed clearly on labels or is available in the appropriate format. We also want to give consumers more information about large oral dosage forms (including large tablets and capsules) when purchasing and taking listed medicines . To help medicines be... MoreClosed 18 July 2024 -
Application to amend the Poisons Standard (November 2024)
This is the new version of the form: Application to amend the Poisons Standard. Help us improve it by providing your feedback via email to the Scheduling Secretariat . This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’ tabs for further details. Please note in accordance with the Scheduling committees meeting dates and decisions timeframes published on the TGA website, applications for the November... MoreClosed 12 July 2024 -
Availability for usability sessions - software and AI based medical devices information
We are improving the structure and content of information about software and Artificial Intelligence (AI) based medical devices on the Therapeutic Goods Administration (TGA) website. We’d like to hear from the medical devices industry, health software developers and consumers who wish to provide input into the design concepts we have developed. If you are interested in participating in a one-hour online usability session between 17 and 28 June 2024 please provide... MoreClosed 18 June 2024 -
Companion diagnostics guidance update- public consultation
The Therapeutic Goods Administration (TGA) is seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the requirements for companion testing, including: A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion... MoreClosed 17 June 2024 -
Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods
The TGA is Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. The TGA regulates therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe. Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated by the TGA and generally need to seek pre-market approval and be included in the ... MoreClosed 14 June 2024 -
Instructions For Use for Medical Devices
The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. The Therapeutic Goods Act 1989 and associated supporting legislation set out the regulatory requirements for medical devices. This includes the information to be provided with a medical device through product label and Instructions for Use (IFU) and the... MoreClosed 4 June 2024 -
Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, JUNE 2024
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 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 22 MAY 2024. ... MoreClosed 22 May 2024 -
Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated
The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Aged Care, regulates therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. Ongoing reforms are undertaken by the TGA to ensure the regulatory oversight of all therapeutic goods remains appropriate. The objective of the reforms is to ensure the sustainability of the Australian regulatory system for therapeutic... MoreClosed 6 May 2024 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS NOVEMBER, 2023
Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the NOVEMBER 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can be accessed through... MoreClosed 17 April 2024 -
Draft guidance: Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials and Investigator’s brochures for medical device clinical trials
The Therapeutic Goods Administration (TGA) is seeking feedback on two draft guidance web pages it will publish. The first page explains how the review of Clinical Trial Notifications (CTNs) for first-in-human clinical trials of the highest-risk implantable and cardiac invasive medical devices will operate. The second page describes the general expectations for the contents of an Investigator’s Brochure, which the TGA may review in certain circumstances as part of the process. These... MoreClosed 12 April 2024 -
Public consultation on Camellia sinensis extracts, amygdalin and hydrocyanic acid in the Poisons Standard
Public consultation on amending the Poisons Standard regarding Camellia sinensis extract, amygdalin and hydrocyanic acid Suggested scheduling amendments for Camellia sinensis extracts, amygdalin and hydrocyanic acid This consultation is in relation to two proposals to: create a new entry for Camellia sinensis (green tea) extract in preparations for internal use, and amend the scheduling for amygdalin and... MoreClosed 12 April 2024 -
[DRAFT] Breast Implant Risk Management Framework
The Therapeutic Goods Administration (TGA) is seeking comments on a proposed Breast Implant Risk Management Framework. The draft framework describes how the TGA identify, communicate and manage the risks associated with breast implants and what patients can do. MoreClosed 26 March 2024 -
Medicine shortages in Australia – Challenges and opportunities
Medicines are essential for the health and wellbeing of Australians. Medicine shortages can occur for various reasons. Unfortunately, some are unavoidable and can cause significant impact. Through our mandatory reporting scheme, the Therapeutic Goods Administration (TGA) is responsible for receiving and publishing reports of shortages and discontinuations of prescription and certain over-the-counter medicines. We work closely with our stakeholders to respond to shortages and... MoreClosed 12 March 2024 -
Adoption of International Scientific Guidelines in Australia R01-2023
The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted. Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external consultation to ensure the international scientific guideline is consistent with prevailing requirements in Australia. The TGA has approximately 370 current adopted international... MoreClosed 4 March 2024 -
Application to amend the Poisons Standard (June 2024)
This is the new version of the form: Application to amend the Poisons Standard. Help us improve it by providing your feedback via email to the Scheduling Secretariat . This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’ tabs for further details. Please note in accordance with the Scheduling committees meeting dates and decisions timeframes published on the TGA website, applications for the June 2024... MoreClosed 1 March 2024 -
Public Consultation - TGA fees and charges proposal 2024-25
Consultation: Fees and Charges Proposal 2024-25 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 2024-25 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed fees and charges prior to seeking approval from the Government for any changes. The TGA, within the... MoreClosed 23 February 2024 -
Pre-meeting public consultation on proposals to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, March 2024
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 March 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 5 February 2024. ... MoreClosed 5 February 2024 -
Proposed quality standards for MDMA and psilocybin
The Therapeutic Goods Administration (TGA) is consulting on two proposed new quality standards for: 3,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA), and psilocybin. The proposed standards include limits on contaminants and synthetic impurities, and accuracy in statement of active ingredients for MDMA and psilocybin. The standards would apply to both compounded and commercially manufactured medicines. ... MoreClosed 31 January 2024
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