137 results
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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... MoreOpened 20 June 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 . ... MoreOpened 29 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... MoreOpened 10 March 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... MoreOpened 10 March 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... MoreOpened 10 March 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... MoreOpened 3 March 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... MoreOpened 28 February 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... MoreOpened 25 January 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... MoreOpened 19 January 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... MoreOpened 10 January 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... MoreOpened 20 December 2021 -
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... MoreOpened 7 December 2021 -
Online Survey: Consent to import, supply or export a medical device that does not comply with the Essential Principles
From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to the TGA. The purpose of this survey is to seek your feedback on the new application form. MoreOpened 1 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... MoreOpened 15 November 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... MoreOpened 18 October 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... MoreOpened 13 October 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... MoreOpened 13 October 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... MoreOpened 12 October 2021 -
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. MoreOpened 1 October 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... MoreOpened 30 September 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... MoreOpened 30 September 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... MoreOpened 17 September 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... MoreOpened 17 September 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... MoreOpened 6 September 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... MoreOpened 26 August 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... MoreOpened 17 August 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... MoreOpened 6 August 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... MoreOpened 6 August 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... MoreOpened 6 August 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... MoreOpened 6 August 2021
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