Events

This session will provide an overview of the open public consultation on the proposed amendments to the conformity assessment procedures for medical devices, outlines the key areas where feedback is sought, and offers an opportunity for participants to ask questions.

This presentation provides a background on our digital transformation and a walkthrough of the Beta (demonstration) version of the new TGA business services portal.

Learn about the temporary risk-based strategies being introduced on 1 July 2025 to expedite the reduction of the Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) backlog.

The Australian UDI Database opened for sponsors to submit data 30 March 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presentations given by the TGA at the 2025 ARCS Annual Conference, 3-4 June 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

Presented at the ARCS Annual Conference 2025.

This presentation provides an overview of TGA’s Good Clinical Practice (GCP) Inspection Program clinical trial compliance activities.

This presentation provides information for external stakeholders about the proposed IVD regulation changes.

Are you interested in applying to be a member of one of the TGA’s Statutory Advisory Committees? Hear first-hand from current members and the Chief Medical Adviser about what this exciting role is like.

This is a Q&A session for industry about the recently published guidance on listed probiotic medicines.

An overview of the amended sponsor portal to include unapproved medical devices and provides guidance on how to apply for consent to import, supply or export medical devices that do not comply with the Essential Principles (EPs).

Guidance on completing updated notification form for new therapeutic vaping products, and information on the re-statement of compliance when requested by TGA.

See the upcoming changes in the PRAC – the new procedure document that will replace the Uniform Recalls Procedure for Therapeutic Goods (URPTG).

Presentations given by the TGA at the ARCS 2025 Regulatory Summit, 19 February 2025

Presentation given at the 2024 ACTA Symposium, in Melbourne

Presentations given by the TGA at the GMP Forum 19-20 November, Melbourne Convention and Exhibition Centre.