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...More
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.
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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...More
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...More
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...More
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...More
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...More
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...More
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...More
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...More
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...More
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...More
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.
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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.
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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...More
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...More
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...More
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...More
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 ...More
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...More
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;...More
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...More
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...More
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...More
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...More
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...More
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...More
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...More
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...More