137 results
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Public consultation on interim decisions to amend the Poisons Standard - ACMS/ACCS & Joint meetings MARCH 2022
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 15-16th 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 16 September 202 2 . All submissions... MoreClosed 16 September 2022 -
Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2022-23
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: Warning statement requiring healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata Liver injury associated with Valeriana officinalis To view the details... MoreClosed 15 September 2022 -
Adoption of 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 29 July 2022 -
Impact of amendments to the application process for inclusion of Class I medical devices in the Australian Register of Therapeutic Goods (ARTG)
The Australian Government is undertaking a significant program to reform 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. The TGA has issued this survey as part of the Government’s reform program. The purpose of this survey is to seek your feedback on the amendments to the application... MoreClosed 31 May 2022 -
Public consultation on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS, June 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 June 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 27 May 2022 . ... MoreClosed 27 May 2022 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS, Joint ACMS-ACCS, November 2021
Scheduling amendments referred to expert advisory committee This consultation is for interim decisions made in relation to applications to amend the Poisons Standard, following advice sought at the 3-4 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 11 April 2022. All submissions received by the deadline will be... MoreClosed 11 April 2022 -
Public consultation on interim decisions to amend the Poisons Standard (isothiazolinones) - Joint ACMS-ACCS, June 2020
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 23-25 June 2020 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 April 2022 . All submissions... MoreClosed 11 April 2022 -
2022 Repurposing medicines
Prescription medicines have been used ‘off-label’ for a given indication for many years to treat conditions or uses that have not been registered in Australia. Whilst this is often aligned with accepted clinical practice, it can lead to patient inequity as it is applied in an ad hoc manner at the discretion of individual doctors. It also can involve significant medicolegal risk in cases where the particular off-label use is not generally accepted in clinical practice. New uses are not... MoreClosed 1 April 2022 -
Proposed update to evidence guidelines for listed medicines
The Therapeutic Goods Administration (TGA) is seeking feedback on the updated ‘Listed medicines evidence guidelines – How to demonstrate efficacy for listed medicines’ (the Guidelines), which is intended to replace the existing ‘ Evidence guidelines – Guidelines on the evidence required to support indications for listed complementary medicines v 3.0, January 2019 ’. Listed medicines do not undergo pre-market assessment but are subject to post-market compliance... MoreClosed 1 April 2022 -
Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals . The proposed 'Priority Review' pathway will align with the pathway in place for medicines and offer a faster formal assessment pathway for biologicals in certain circumstances. This will allow consumers with life-threatening diseases or seriously debilitating conditions to access these treatments in less time if the assessment... MoreClosed 1 April 2022 -
Survey on publication of listed medicine compliance review results
The TGA is seeking feedback on how effectively information relating to the results of listed medicine compliance reviews is being conveyed to consumers. MoreClosed 31 March 2022 -
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
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