136 results
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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 -
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... MoreClosed 1 September 2021 -
Public consultation on interim decisions to amend the Poisons Standard (nitrous oxide) - Joint ACMS-ACCS, March 2021
Scheduling amendments referred to expert advisory committee This consultation is for an interim decision made in relation to an application to amend the Poisons Standard, following advice sought at the 17-18 March 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) in joint session. The closing date for this consultation is close of business 27 August 2021 . All submissions received by the... MoreClosed 27 August 2021 -
SURVEY: Personalised medical devices - further resources for stakeholders
From 25 February 2021, a new framework for regulating personalised medical devices will commence. Comprehensive guidance about the framework can be found at: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices The Therapeutic Goods Administration (TGA) is conducting an education campaign to help stakeholders to understand the new framework and meet their regulatory obligations, ensuring minimal interruption to the supply of personalised... MoreClosed 25 August 2021 -
NOTIFICATION FORM: Transition arrangements for medical devices that record patient images, and anatomical models
This form should be used by manufacturers and sponsors of medical devices that record patient images or that are anatomical models, and that will be reclassified by the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for transition if: they are medical devices intended to record patient images that are acquired using a method that relies on energy outside the visible spectrum; or they... MoreClosed 25 August 2021 -
NOTIFICATION FORM: Transition arrangements for software-based medical devices
Please note this form closes at 11.59pm on 24 August 2021 This form should be used by sponsors and manufacturers of software-based medical devices that will need to be included in the ARTG at a higher classification as a result of the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for transition if: They are software-based medical devices intended for: diagnosing and screening for a disease or condition;... MoreClosed 24 August 2021 -
Australian Register of Therapeutic Goods (ARTG) Search - Feedback Survey
As part of the TGA Digital Transformation, the public search of the Australian Register of Therapeutic Goods (ARTG) is under review so we can better meet your needs. The ARTG is a register of therapeutic goods that can be lawfully supplied in Australia. We welcome your feedback on the current public ARTG Search on the TGA website MoreClosed 20 August 2021 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS/ACCS meetings, March 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 17-18 March 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 17 August 2021 . All submissions received... MoreClosed 17 August 2021 -
Proposed refinements to the Regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin
In early 2019 the Therapeutic Goods Administration (TGA) conducted a public consultation seeking feedback on a proposal to introduce new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied to skin, that are absorbed or dispersed. The proposed regulatory changes supported the commitment made to align Australian medical device regulations, where possible and appropriate, with the European... MoreClosed 13 August 2021 -
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 (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 -
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 (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 (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 -
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 -
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): 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): 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 -
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
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