173 results
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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... MoreOpened 2 July 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... MoreOpened 24 June 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... MoreOpened 24 June 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... MoreOpened 11 June 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... MoreOpened 30 May 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. ... MoreOpened 23 April 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 ... MoreOpened 15 April 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... MoreOpened 15 April 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... MoreOpened 3 April 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... MoreOpened 15 March 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... MoreOpened 15 March 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... MoreOpened 12 March 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... MoreOpened 4 March 2024 -
Public consultation on Camellia sinensis extract, 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... MoreOpened 1 March 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. MoreOpened 27 February 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... MoreOpened 12 February 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... MoreOpened 25 January 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... MoreOpened 22 January 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. ... MoreOpened 5 January 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. ... MoreOpened 8 December 2023 -
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... MoreOpened 8 November 2023 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2023
Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to the other substances that were discussed at the JUNE 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint meeting of the 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... MoreOpened 5 October 2023 -
Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, NOVEMBER 2023
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 NOVEMBER 2023 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 29 September... MoreOpened 1 September 2023 -
MDSAP survey
The TGA is seeking feedback from Australian Sponsors about the Medical Device Single Audit Program (MDSAP). By completing this survey, your response will help us to better understand any concerns with the operation of the program. Sponsors may reach out to applicable Manufacturers for help answering specific questions on audit activities if necessary, although the intent of the survey is to better understand the Sponsor interactions during MDSAP audits. The following survey should... MoreOpened 25 August 2023 -
ODC Monitoring and Compliance Section Cannabis Waste Management Survey
The Office of Drug Control Monitoring and Compliance Section (MaCS) are seeking clarification of the nature and effectiveness of the various waste management and destruction processes employed by licence holders. This survey will inform ODC decision makers on effective waste management and destruction measures being used. The survey will be used by the ODC to develop guidance and educational materials for industry and enable the ODC to better support licence holders. MoreOpened 25 August 2023 -
Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2023-24
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: Curcuma species and curcumin and the risk of liver injury Green tea extract and the risk of liver injury Safe levels of benzophenone Clarification of the requirements for soy phosphatidylserine-enriched... MoreOpened 3 August 2023 -
Public consultation on interim decision to amend the Poisons Standard - Joint ACMS-ACCS June 2023 - LEAD
Interim decision regarding lead following the discussions at the Joint meeting of ACMS-ACCS held in June 2023. This consultation is the interim decision for LEAD (in anti-fouling paints) that was discussed at the June 2023 Joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . Kindly note that the interim decision in relation to lead may differ from the initial proposal. Please read through the proposed... MoreOpened 3 August 2023 -
Public consultation: Proposed application audit framework for medical devices
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program. The TGA is responsible for regulating the import, export, and supply of medical devices, including... MoreOpened 26 July 2023 -
Proposed New Guidelines for the Quality of Listed Probiotic Medicines
The Therapeutic Goods Administration (TGA) is seeking feedback on the proposed new ‘Guidelines for the Quality of Listed Probiotic Medicines (the Guidelines)’. Probiotics are defined as live microorganisms that when administered in adequate amounts, are proposed to confer a health benefit on the host. The quality requirements for listed probiotic medicines are complex to piece together. The purpose of these Guidelines is to help sponsors and manufacturers meet the... MoreOpened 24 July 2023 -
Application to amend the Poisons Standard (March 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 March 2024... MoreOpened 15 July 2023
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