169 results
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Questionnaire for continuing panel members
We want to know what you think about the TGA so we can enhance our support for all panel members. This questionnaire should only take you about 7-10 minutes to complete. The questionnaire focuses on key issues such as: the quoting process administrative correspondence the guidance and direction received from the TGA delegate interaction with the TGA during the evaluation phase; and TGA feedback. Responses to this questionnaire will be used... MoreClosed 23 December 2014 -
AusPAR Survey
The TGA would like to know what you think about the Australian Public Assessment Reports (AusPARs) for prescription medicines. This questionnaire should only take a couple of minutes to complete and will help us to understand who the audience of an AusPAR is, what AusPARs are used for and how useful their content is to our external stakeholders. MoreClosed 31 July 2016 -
GMP Forum 2018 - Survey
TGA Conference Evaluation online form 2018 GMP Forum 26 June 2018 MoreClosed 8 July 2018 -
Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media | Therapeutic Goods Administration (TGA)
The Australian Government endorsed a significant program of reform to further strengthen the regulation of medicines and medical devices in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates these products, and is responsible for implementing the Government's reforms. Medical devices are regulated in Australia having regard to the risks (to the individual or public health) considered in the context of the device’s... MoreClosed 29 April 2019 -
TGA SME Assist Workshop: Meeting Your Obligations (Perth)
Navigating the re gulatory maze can be a challenge, especially if you're new to regulation. SME Assist in partnership with The Western Australian Health Translation Network presents Meeting Your Obligations: a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation. This may include: small to medium enterprises (SMEs) start-ups researchers If you are making therapeutic claims about a product or... MoreClosed 13 September 2019 -
Consultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicines
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain. To make sure the standard is clear, meaningful and fit for purpose. We are seeking feedback on its suitability and potential impacts. Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020 Guidance for TGO... MoreClosed 20 August 2020 -
Notice of interim decisions to amend (or not to amend) the current Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS meeting, 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 scheduling in 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) . All submissions received will be... MoreClosed 13 October 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 -
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 -
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 -
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 -
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 -
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 -
NOTIFICATION FORM: Clinical decision support software exemption
This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 . The exemption applies to medical devices that are clinical decision support software (CDSS) that meet all three of the following criteria: intended by its manufacturer to be for the sole purpose of providing or supporting a recommendation to a... MoreOpened 4 January 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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 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 -
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
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