137 results
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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 - 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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 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 -
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 -
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... MoreOpened 4 August 2022 -
Proposed regulatory changes for clinical trials of medical devices
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed regulatory changes to strengthen safety oversight of clinical trials for medical devices. The changes are: To increase the degree of regulatory oversight of clinical trials of certain unapproved, high-risk medical devices. To include clinical trials of all medical devices in Australia’s Good Clinical Practice Inspection Program (to enable selected trials and documentation supporting... MoreOpened 17 August 2022 -
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... MoreOpened 19 August 2022 -
Consultation: Product Information as a package insert in boxed injectables
The Therapeutic Goods Administration (TGA) is requesting feedback on the current usage of the information included with boxed injectables and whether the requirement to include a paper Product Information (PI) as a package insert in boxed injectables is still relevant for those administered by healthcare professionals. In Australia the PI is required to be provided both in the box of injectables and also as an electronic document available on the TGA website. The PI provides... MoreOpened 24 August 2022 -
UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue 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 and Aged Care, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the... MoreOpened 31 August 2022 -
Public consultation on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS, NOVEMBER 2022
Scheduling amendments referred to expert advisory committee Please note that this consultation does not include public submissions for paracetamol. To visit the consultation for paracetamol, please see the below link: Paracetamol consultation hub 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 2022 ... MoreOpened 1 September 2022 -
Public consultation on proposed amendments to the Poisons Standard (paracetamol) - ACMS, November 2022
Potential Scheduling amendments referred to expert advisory committee. Please note that this consultation is for paracetamol only. If you wish to comment on other substances discussed at the November 2022 meetings, please see the link below: Consultation for November 2022 (other substances) This consultation is for possible delegate-initiated proposals to amend the Poisons Standard with regards to paracetamol. The suggested amendments and any... MoreOpened 14 September 2022 -
Consultation: Regulatory options to allow references to the TGA in therapeutic goods advertising
The Therapeutic Goods Administration (TGA) is considering regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels). We are seeking feedback on: whether references to the TGA should be allowed in therapeutic goods advertising the class or classes of therapeutic goods, if any, that should be allowed to refer to the TGA options for what a reference to the TGA could... MoreOpened 26 September 2022 -
User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version
The Database of Adverse Event Notifications (DAEN) – medicines is the TGA’s public database displaying information about reports of suspected adverse events received in relation to medicines (including vaccines) and biological therapies in Australia. The TGA have created a trial (beta) version of the DAEN – medicines with updated technology to improve its performance, reliability and user experience. The beta version was created to address a decline in the older... MoreOpened 28 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... MoreOpened 29 September 2022 -
Notification form: Lapses in medical device conformity assessment certification
Please use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). Conformity assessment certification may lapse due to the certification expiring, or if it has been suspended or revoked. Notifying the TGA of any lapse in certification is a legal requirement. Changes to the medical device directive (93/42/EEC) and the IVD Directive (98/79/EC) along with disruptions due to the... MoreOpened 3 October 2022 -
Boundary and combination products guidance - medicines, medical devices, and biologicals
The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals ’ . The purpose of this draft guidance is to assist sponsors and manufacturers in determining the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices. The draft guidance aims to provide clarity on which regulatory pathway is... MoreOpened 7 October 2022 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS JUNE INTERIM DECISIONS 2022
Scheduling amendments referred to expert advisory committee Please note that there is a separate consultation for interim decisions relating to PSILOCYBINE and MDMA which can be found by clicking the link below: Psilocybine and MDMA consultation 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 June 2022 meetings of the Advisory Committee on... MoreOpened 21 October 2022
137 results.
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