126 results
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Public Consultation - Fees and charges proposal 2022-23
The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA’s proposed fees and charges for the 2022-23 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed options, prior to seeking approval from the Government for any changes. The Therapeutic Goods Administration (TGA) within the Department of Health is responsible... MoreClosed 7 March 2022 -
Adoption of certain international scientific guidelines in Australia
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 20 February 2022 -
Improving access to medicine adverse event data – sponsor survey
The Therapeutic Goods Administration (TGA) monitors the safety of medicines (including vaccines) by collecting and assessing reports of adverse events and taking regulatory action to improve medicine safety. The sponsors of medicines in Australia also have pharmacovigilance responsibilities, including the need to collect and assess adverse event reports and inform the TGA where any significant safety issues have been identified for their products. The Medicines Adverse Event Data... MoreClosed 18 February 2022 -
Proposal to improve patient access to critical medicines in acute-care settings
The Therapeutic Goods Administration (TGA) is seeking feedback on whether an amendment to the Therapeutic Goods Regulations 1990 is required in order to improve patient access to critical medicines in acute-care settings. The current regulatory framework does not permit hospital pharmacists to extemporaneously compound medicines before a specific patient is identified. In particular emergency situations, this puts patients at risk. After preliminary discussions with... MoreClosed 7 February 2022 -
Public consultation on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS, March 2022
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 15-17 March 2022 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 31 January... MoreClosed 31 January 2022 -
TGA's New Post Market Review Compliance Dashboard
From 19 October 2020, how the TGA engages with the sponsors for post market reviews has changed. A new medical device Post Market Review Compliance Dashboard has been developed in TBS to respond to post market reviews. The new compliance dashboard will provide the sponsors with an efficient and secure way of responding to post market reviews. The purpose of this survey is to seek your feedback on the new Post Market Review Compliance Dashboard. MoreClosed 31 December 2021 -
Potential regulatory options for ‘export only’ biologicals
The Therapeutic Goods Administration (TGA) is seeking feedback on potential options for the regulation of biological therapeutic goods (biologicals) manufactured in Australia for export only (and not for supply in Australia). Biologicals are human tissue and cell-derived products and live animal cell, tissues or organs. Currently, biologicals included in the Australian Register of Therapeutic Goods (ARTG) can be exported but they are not permitted to vary from the... MoreClosed 22 December 2021 -
Potential for Mandatory Reporting of Medical Device Adverse Events by Healthcare Facilities in Australia
The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates medical devices, and is responsible for implementing the Government’s reforms. We released this Discussion Paper seeking feedback on potential changes to... MoreClosed 13 December 2021 -
Application for consent to import, supply or export a medical device that does not comply with the Essential Principles: Non-compliant Patient Information Materials
This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles. There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989 , for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance, unless consent has been granted by... MoreClosed 30 November 2021 -
Application for consent to import, supply or export a medical device that does not comply with the Essential Principles
This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles. There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989 , for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance, unless consent has been granted by the Secretary... MoreClosed 30 November 2021 -
Public consultation on interim decisions to amend the Poisons Standard (sodium nitrite) - Joint ACMS-ACCS, June 2021
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 June 2021 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 11 November 2021 . All submissions... MoreClosed 11 November 2021 -
Public consultation on interim decisions to amend the Poisons Standard - Joint ACMS-ACCS, June 2021
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 June 2021 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 11 November 2021 . All submissions... MoreClosed 11 November 2021 -
Public consultation on interim decisions to amend the Poisons Standard - ACCS, June 2021
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 22 June 2021 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 11 November 2021 . All submissions received by the deadline will be considered by the delegate before... MoreClosed 11 November 2021 -
Consultation on Draft Guidance: Assistive Technologies and the Therapeutic Goods (Excluded Goods) Determination 2021
We have extended the timeframe for submissions to this consultation. We will commence analysing submissions from 22 October 2021. However some stakeholders have requested more time to submit their comments, so the capacity to make submissions will remain open until Friday 5 November 2021. We welcome any feedback stakeholders can provide on this issue. Stakeholders can also provide feedback by email to LowRiskDevices@health.gov.au ________ The Therapeutic Goods... MoreClosed 5 November 2021 -
Public consultation on interim decisions to amend the Poisons Standard (oral contraceptives) - ACMS, June 2021
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 23-24 June 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The closing date for this consultation is close of business 1 November 2021 . All submissions received by the deadline will be considered by the delegate... MoreClosed 1 November 2021 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, June 2021
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 23-24 June 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The closing date for this consultation is close of business 1 November 2021 . All submissions received by the deadline will be considered by the delegate... MoreClosed 1 November 2021 -
Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS and Joint ACMS-ACCS, November 2021
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 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 7... MoreClosed 7 October 2021 -
Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2021-22
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 December 2021 . The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients... MoreClosed 29 September 2021 -
Proposed minor changes to Required Advisory Statements for Medicine Labels (RASML): Chlorhexidine, hydrocortisone, ibuprofen
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 Required Advisory Statements for Medicine Labels (RASML) . The proposed changes involve minor changes to existing RASML entries to correct or clarify intended requirements and in most cases should... MoreClosed 17 September 2021 -
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Melatonin
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 advisory statements for melatonin-containing medicines in RASML follows recent down-scheduling of melatonin when supplied under specific conditions, from Schedule 4 to Schedule 3 of the Poisons... MoreClosed 17 September 2021 -
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Mometasone
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 for Medicine Labels (RASML) . The proposal to include advisory statements for mometasone-containing medicines in RASML follows recent down-scheduling of mometasone for dermal use when supplied... MoreClosed 17 September 2021 -
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Triptans
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 Advisory Statements for Medicine Labels (RASML) . The proposal to include advisory statements for triptan-containing medicines in RASML follows recent down-scheduling of triptans when supplied... MoreClosed 17 September 2021 -
Proposed refinements to the requirements for medical device patient information materials
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 USA and Canada there are requirements already in force. In Australia, in late 2017, the Government approved regulations that require patient information materials to be supplied with... MoreClosed 1 September 2021 -
Public consultation on interim decisions to amend the Poisons Standard (nitrous oxide) - Joint ACMS-ACCS, March 2021
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 the Advisory Committee on Chemicals Scheduling (ACCS) in joint session. The closing date for this consultation is close of business 27 August 2021 . All submissions received by the... MoreClosed 27 August 2021 -
NOTIFICATION FORM: Transition arrangements for medical devices that record patient images, and anatomical models
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 transition if: they are medical devices intended to record patient images that are acquired using a method that relies on energy outside the visible spectrum; or they... MoreClosed 25 August 2021 -
SURVEY: Personalised medical devices - further resources for stakeholders
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 Administration (TGA) is conducting an education campaign to help stakeholders to understand the new framework and meet their regulatory obligations, ensuring minimal interruption to the supply of personalised... MoreClosed 25 August 2021 -
NOTIFICATION FORM: Transition arrangements for software-based medical devices
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) Regulations 2002 from 25 February 2021. Devices are eligible for transition if: They are software-based medical devices intended for: diagnosing and screening for a disease or condition;... MoreClosed 24 August 2021 -
Australian Register of Therapeutic Goods (ARTG) Search - Feedback Survey
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 current public ARTG Search on the TGA website MoreClosed 20 August 2021 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS/ACCS meetings, March 2021
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 Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 17 August 2021 . All submissions received... MoreClosed 17 August 2021 -
Proposed refinements to the Regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin
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 to skin, that are absorbed or dispersed. The proposed regulatory changes supported the commitment made to align Australian medical device regulations, where possible and appropriate, with the European... MoreClosed 13 August 2021
126 results.
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