127 results
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Adoption of International Scientific Guidelines in Australia R01-2023
The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted. Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external consultation to ensure the international scientific guideline is consistent with prevailing requirements in Australia. The TGA has approximately 370 current adopted international... MoreClosed 4 March 2024 -
Medicine shortages in Australia – Challenges and opportunities
Medicines are essential for the health and wellbeing of Australians. Medicine shortages can occur for various reasons. Unfortunately, some are unavoidable and can cause significant impact. Through our mandatory reporting scheme, the Therapeutic Goods Administration (TGA) is responsible for receiving and publishing reports of shortages and discontinuations of prescription and certain over-the-counter medicines. We work closely with our stakeholders to respond to shortages and... MoreClosed 12 March 2024 -
[DRAFT] Breast Implant Risk Management Framework
The Therapeutic Goods Administration (TGA) is seeking comments on a proposed Breast Implant Risk Management Framework. The draft framework describes how the TGA identify, communicate and manage the risks associated with breast implants and what patients can do. MoreClosed 26 March 2024 -
Draft guidance: Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials and Investigator’s brochures for medical device clinical trials
The Therapeutic Goods Administration (TGA) is seeking feedback on two draft guidance web pages it will publish. The first page explains how the review of Clinical Trial Notifications (CTNs) for first-in-human clinical trials of the highest-risk implantable and cardiac invasive medical devices will operate. The second page describes the general expectations for the contents of an Investigator’s Brochure, which the TGA may review in certain circumstances as part of the process. These... MoreClosed 12 April 2024 -
Public consultation on Camellia sinensis extracts, amygdalin and hydrocyanic acid in the Poisons Standard
Public consultation on amending the Poisons Standard regarding Camellia sinensis extract, amygdalin and hydrocyanic acid Suggested scheduling amendments for Camellia sinensis extracts, amygdalin and hydrocyanic acid This consultation is in relation to two proposals to: create a new entry for Camellia sinensis (green tea) extract in preparations for internal use, and amend the scheduling for amygdalin and... MoreClosed 12 April 2024 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS NOVEMBER, 2023
Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the NOVEMBER 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can be accessed through... MoreClosed 17 April 2024 -
Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated
The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Aged Care, regulates therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. Ongoing reforms are undertaken by the TGA to ensure the regulatory oversight of all therapeutic goods remains appropriate. The objective of the reforms is to ensure the sustainability of the Australian regulatory system for therapeutic... MoreClosed 6 May 2024
127 results.
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