Publications

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.

Public submissions on interim decisions for scheduling matters referred to the ACMS #40, ACCS #35 and Joint ACMS-ACCS #32 meetings held in November 2022

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

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

Public submissions on interim decisions for scheduling matters referred to ACMS, ACCS and Joint meetings held in June 2022

Public submissions on interim decisions for scheduling matters referred to ACMS, ACCS and Joint meetings held in November 2022

Public submissions on interim decisions for scheduling matters referred to ACMS, ACCS and Joint meetings held in November 2021

Public submissions on interim decisions for scheduling matters referred to ACMS, ACCS and Joint meetings held in June 2021

Results report for the 2022 TGA stakeholder survey

Public submissions made in response to the public consultation on proposed amendments to the Poisons Standard - November 2021 ACMS/ACCS meetings

Public submissions made in response to the public consultation on proposed amendments to the Poisons Standard - June 2022 ACMS/ACCS meetings

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.

The report has been published, including MTP Connect's major findings and TGA's proposed response to the major recommendations.

The 2022-23 TGA business plan

Prescription opioid tracking research

TGA's Half-yearly Performance Snapshot Report for July - December 2021 is now available.

TGA publishes a Half-Yearly Performance Report (The Snapshot). The Snapshot provides statistical information on our performance highlights for the July to December period