126 results
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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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 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 -
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 -
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 -
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 -
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 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... MoreClosed 28 September 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 ... MoreClosed 29 September 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... MoreClosed 5 October 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... MoreClosed 11 October 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... MoreClosed 14 October 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... MoreClosed 26 October 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... MoreClosed 7 November 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 10 November 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... MoreClosed 20 November 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... MoreClosed 24 November 2022 -
Public consultation on interim decisions to amend the Poisons Standard - JUNE ACMS INTERIM DECISIONS FOR PSILOCYBINE AND MDMA 2022
Scheduling amendments referred to expert advisory committee Please note: this is a consultation for the interim decisions relating to PSILOCYBINE and MDMA ONLY. If you wish to provide comments on the other items considered at the ACMS and ACCS meetings in June 2022, please visit the alternate consultation hub by clicking the link below: Consultation for other substances considered in June 2022 This consultation is for interim decisions made in relation to Psilocybine... MoreClosed 24 November 2022 -
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. MoreClosed 1 December 2022 -
International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names
The Therapeutic Goods Administration (TGA) is seeking views on medicine ingredient names that must be displayed as both the old and new ingredient name ('dual labelled') on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents until 30 April 2023 as part of International harmonisation of ingredient names (IHIN) . We are seeking feedback on: whether health professionals, consumers and health systems are ready for dual labelling to end... MoreClosed 19 December 2022
126 results.
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