126 results
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Proposed refinements to the regulation of personalised medical devices
On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are designed and manufactured for individual patients (otherwise known as 'personalised' medical devices). The key change introduced under the Framework is a change to the definition of a custom-made medical device. Custom-made medical devices are exempt products. In Australia, all... MoreClosed 21 July 2021 -
Remaking of standards and legislative instruments for human cell and tissue products, blood and blood components
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021. We are seeking feedback to make sure the proposed changes: improve clarity on technical requirements ensure alignment with international best practice and standards bring legislation into alignment with... MoreClosed 11 July 2021 -
Proposed improvements to the Therapeutic Goods Advertising Code
The Therapeutic Goods Administration (TGA) is seeking feedback on options to improve the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The Code is the compliance standard that prescribes the minimum requirements for the lawful advertising of therapeutic goods to the general public in Australia. The proposed improvements are aimed at increasing advertisers’ understanding of the requirements of the Code, ensuring provisions work as intended, and... MoreClosed 18 June 2021 -
Public consultation on proposed amendments to the Poisons Standard - ACCS, June 2021
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 2021 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 4 June 2021. All submissions received by the deadline will be considered by... MoreClosed 4 June 2021 -
SURVEY: Software based Medical Devices – further resources for stakeholders
From 25 February 2021, a new framework for regulating software as a medical device will commence. The Regulation of software based medical devices details these changes, and additionally the following guidance documents have also been published to assist users understand the various processes relevant to software as a medical device (SaMD): Is my software regulated? How the TGA regulates software based medical devices Regulatory changes... MoreClosed 3 June 2021 -
Public consultation on proposed amendments to the Poisons Standard (oral contraceptives) - ACMS, June 2021
Scheduling amendments referred to expert advisory committee This consultation is for applications to amend the Poisons Standard in relation to substances used in oral contraceptives. The scheduling proposals, and any submissions received, will be considered at the June 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The closing date for this consultation is close of business 27 May 2021. All submissions received by the deadline... MoreClosed 27 May 2021 -
Public consultation on proposed amendments to the Poisons Standard (sodium nitrite) - Joint ACMS-ACCS, June 2021
CONTENT WARNING The Department of Health acknowledges the devastating effects associated with acts of self-harm on individuals, their families, friends and communities. This consultation relates to information on self-poisonings that some people may find distressing. If you, or someone you know, is in need of additional support, please contact any of the below crisis support helplines. Support services and information sources Adult Lifeline : 13 11 14 ... MoreClosed 27 May 2021 -
Public consultation on proposed amendments to the Poisons Standard - ACMS, June 2021
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 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The closing date for this consultation is close of business 27 May 2021. All submissions received by the deadline will be considered by... MoreClosed 27 May 2021 -
Public consultation on proposed amendments to the Poisons Standard (hand sanitisers) - Joint ACMS-ACCS, June 2021
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 2021 joint meeting 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 2021. ... MoreClosed 27 May 2021 -
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Methyl salicylate
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing methyl salicylate for dermal use , for inclusion in the Required Advisory Statements for Medicine Labels (RASML) . The proposal to include advisory statements for methyl salicylate-containing medicines in RASML follows previously implemented requirements for... MoreClosed 18 May 2021 -
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Lidocaine (lignocaine)
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on addition of a proposed new required advisory statement for labels of non-prescription medicines containing more than 1.5 per cent lidocaine (lignocaine) for topical oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document. The required advisory statement “Do not use for teething pain in children” is proposed for preparations for topical oral... MoreClosed 18 May 2021 -
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on changes to current requirements for advisory statements for labels of non-prescription medicines containing antihistamines indicated for short term use in insomnia (diphenhydramine, doxylamine and promethazine), as included in the Required Advisory Statements for Medicine Labels (RASML) document. MoreClosed 18 May 2021 -
Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Menthol
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on the addition of proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing menthol for dermal use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) . The proposal to include advisory statements for menthol in RASML follows previously implemented requirements for advisory statements on labels of... MoreClosed 18 May 2021 -
Building a more robust medicine supply: proposals to help prevent, mitigate and manage medicine shortages
The Therapeutic Goods Administration (TGA) is seeking feedback on proposals to help ensure ongoing, reliable supply of important medicines. Medicine shortages have been of particular concern during the COVID-19 pandemic. We have been reviewing the ways in which we can better assist affected Australian patients and their healthcare providers. Specifically, we are seeking feedback on possible reforms that would: prioritise the evaluation and registration process... MoreClosed 17 May 2021 -
Proposed regulatory options for medical devices containing nanomaterials
The Australian Government is undertaking a significant program of reform to 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. We have issued this consultation paper as part of the reform program. In 2015, the Report of the Expert Panel Review of Medicines and Medical Devices Regulation... MoreClosed 9 April 2021 -
TGO 110 – Standard for Vaporiser Nicotine - Consultation
The Therapeutic Goods Administration (TGA) is seeking comments on a proposed standard for vaporiser nicotine products. Vaporiser nicotine products are nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs). This includes vape liquids, e-liquids and e-juices that contain nicotine and/or nicotine salts. This does not include other nicotine replacement therapies (NRTs) containing... MoreClosed 31 March 2021 -
Repurposing of Prescription Medicines
Repurposing is the process of identifying new uses (or ‘indications’) for medicines. In some cases, prescription medicines may have been used ‘off-label’ for many years to treat conditions that they do not have formal regulatory approval (i.e. are not registered) for. Whilst this may be accepted clinical practice, obtaining formal regulatory approval for the repurposed indication can lead to wider and safer use as it means that the evidence base for such clinical use has been... MoreClosed 30 March 2021 -
Proposal for clarifying regulatory requirements for residual claims for disinfectants
This consultation is to obtain feedback in relation to proposals to provide clarity on residual claims for disinfectants. The Therapeutic Goods Administration (TGA) has received a number of enquiries relating to residual activity claims for disinfectants, including whether statements can be made for disinfectants such as ‘residual activity for up to 30 days’, and what testing methods should be used to provide evidence for these claims. At present, there is no... MoreClosed 26 March 2021 -
Public Consultation - Fees and charges proposal 2021-22
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 2021-22 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 17 March 2021 -
Public consultation on interim decisions to amend the Poisons Standard - November 2020 ACMS/ACCS meetings
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 4-5 November 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 4 March 2021 . All submissions received by the... MoreClosed 4 March 2021 -
Removing redundant processes for entering certain formulation information into a therapeutic goods application
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to streamline how information about certain therapeutic goods formulations is entered into TGA electronic systems when seeking market approval. Specifically, we propose to discontinue entering certain types of formulations into a subordinate database of ingredient mixtures (known as the Proprietary Ingredients Table) before they are selected into therapeutic goods applications for inclusion in the ... MoreClosed 24 February 2021 -
Agent access to notifications on Post Market Review Medical Devices Compliance dashboard
From 19 October 2020, the process by which the Therapeutic Good Administration (TGA) engages with the sponsors 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 is providing the sponsors with an efficient and secure way of responding to post market reviews. At present, the Post Market Review Medical Devices Compliance portal does not grant access to... MoreClosed 17 February 2021 -
Consultation: Australian Medical Device Regulations definition of Central Circulatory System (CCS)
The Australian Government is undertaking a significant program of reform to 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. We have issued this consultation paper as part of the reform program. In 2019, the TGA consulted on changes to the classification rules in Proposed changes to the... MoreClosed 10 February 2021 -
Public consultation on proposed amendments to the Poisons Standard - March 2021 ACMS/ACCS meetings
Scheduling amendments referred to expert advisory committee This pre-meeting consultation is for applications and delegate initiated proposals to amend the scheduling in the Poisons Standard for certain substances. The scheduling amendments and any submissions received will be considered at either the meeting of the Advisory Committee on Medicines Scheduling (ACMS) , meeting of the Advisory Committee on Chemicals Scheduling (ACCS) , or a... MoreClosed 27 January 2021 -
Exploring options for the introduction of an Australian Unique Device Identification (UDI) System: UDI consultation paper 2
The Australian Government is undertaking a significant program of reform to 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. We have issued this consultation paper as part of the reform program. This is the second consultation paper published by the TGA relating to the proposed... MoreClosed 24 December 2020 -
Proposed Enhancements to Adverse Event Reporting for Medical Devices - Industry
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 consultation paper as part of the Government’s reform program . The purpose of this consultation paper is to seek feedback on proposals... MoreClosed 24 December 2020 -
Proposed Enhancements to Adverse Event Reporting for Medical Devices - Consumers
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 consultation paper as part of the Government’s reform program. The purpose of this consultation paper is to seek feedback on proposals that aim... MoreClosed 24 December 2020 -
Compounded medicines and good manufacturing practice (GMP)
The current guidance Compounded medicines and good manufacturing practice (GMP) was developed in relation to the PIC/S Guide to GMP for Medicinal Products PE-009-8 15 January 2009, following public consultation in 2015. This document provides guidance on the interpretation of the PIC/S Guide to GMP for manufacturers licenced by the TGA to manufacture compounded and dispensed therapeutic goods. Following the adoption by the TGA of the PIC/S Guide to GMP PE009-14 as the Manufacturing... MoreClosed 18 December 2020 -
Medicinal Cannabis Permit Reform
The Department of Health through the Office of Drug Control (ODC) is seeking comments from interested parties on a review of the structure, design and administrative processes for medicinal cannabis related permits (the review). This review is part of the broader reforms being implemented as a result of the statutory Review of the Narcotic Drugs Act 1967 undertaken in 2019 by Professor John McMillan AO. MoreClosed 18 December 2020 -
Notice of an interim decision to amend the current Poisons Standard in relation to nicotine - Joint ACMS-ACCS meeting, June 2020
Interim decision to amend the current Poisons Standard in relation to nicotine, Joint ACMS-ACCS meeting #25, June 2020 This consultation is for an interim decision to amend the scheduling of nicotine in the current Poisons Standard, following advice sought at the 23 June 2020 meeting of the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25, June 2020). The interim decision on nicotine scheduling is a separate process... MoreClosed 12 November 2020
126 results.
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