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
...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...More
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...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...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 ...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...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...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...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...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...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...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...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...More
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...More
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...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...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...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...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...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...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)...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...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...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...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...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...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...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...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...More