Publications

This guide applies to the manufacture of medicines, active pharmaceutical ingredients and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989.

An overview of the Medicines Repurposing Program's purpose and history.

This publication outlines our plan to transition to a paperless model for Special Access Scheme (SAS) and Authorised Prescriber (AP) submissions.  From 1 July 2024 we will only accept submissions via the SAS/AP Online System.

This report provides information about our regulatory performance from 1 July 2022 to 30 June 2023.

We survey our stakeholders each year to help evaluate our performance and identify ways of improving.

Read our 2023 stakeholder survey report, which aims to improve the way we work with our stakeholders.

MDSU provides practical advice and information about medical device safety.

The strategy outlines the approach we will use to identify, engage with, and educate stakeholders about regulatory requirements and our compliance outcomes.

Overview of therapeutic goods advertising complaints handling and compliance for 2022-23

Access our report on medical devices manufactured at the point-of-care - analysis of survey results by sector.

Read our business plan 2023-24 to find out about our strategic priorities and activities.

Documents released under the FOI Act in the 2022/23 financial year

This Cost Recovery Implementation Statement provides information on how the TGA, within the Department of Health, implements and cost recovers its regulatory activities.

Mandatory reporting of medical device adverse events by healthcare facilities to the TGA has now commenced, with a period of voluntary reporting in place from March 2025 until 20 March 2026.

The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.

The Action Plan will further improve Australia’s medical device regulatory system, placing patient safety first.

The report cards show the progress made by the TGA in the 3 strategies that make up the Action Plan for Medical Devices.

Results report for the 2022 TGA stakeholder survey

Documents released under the FOI Act in the 2021/22 financial year

This Cost Recovery Implementation Statement provides information on how the TGA, within the Department of Health, implements and cost recovers its regulatory activities

The 2020-21 TGA Regulator Performance Report has now been published

The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.

TGA's Access Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition.

Overview of therapeutic goods advertising complaints handling and compliance for 2021-22

This report was commissioned by the TGA in response to concerns of increasing prevalence of intentional paracetamol poisoning, especially among young people, and involving paracetamol obtained via general sale in supermarkets and convenience stores.