Australia Profile Updated
The Australia profile in ClinRegs has been reviewed and updated with the following information, which is current as of September 30, 2025:
- New Therapeutic Goods Administration (TGA) webpages containing clinical trial approval (CTA) process information and forms (See Scope of Assessment, Ethics Committee, Scope of Review, and the Clinical Trial Lifecycle topic)
- Updated TGA fees related to clinical trials (See Regulatory Fees)
- Updated TGA good clinical practice inspection guideline and related webpage (See Scope of Assessment and Risk & Quality Management)
- Additional details related to the types of therapeutic goods the TGA regulates (See Regulatory Authority)
- Reference to an Office of the Australian Information Commissioner guideline regarding the Australian Privacy Principles (See Personal Data Protection)
- TGA’s implementation of version 17 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products and a related transition document (See the Investigational Products topic)
- Updated Department of Health, Disability and Ageing links throughout the profile
Sources Added During this Update:
(Guidance) Australian Privacy Principles Guidelines (G-APP) (Last Updated December 2022)
Office of the Australian Information Commissioner
(Document) Transition to New GMP Requirements for Medicinal Products: A Notice About the Implications of Adopting the PIC/S Guide to GMP PE009-17 (AUS-95) (Version 1.0) (August 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) Australian Clinical Trial Reforms (AUS-91) (Last Updated April 9, 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) Clinical Trial Notification (CTN) Scheme (AUS-87) (Last Updated April 9, 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) CTA Scheme Forms (AUS-89) (Last Updated August 29, 2024)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) Good Clinical Practice (GCP) Inspection Program (AUS-90) (Last Updated August 29, 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) How We Regulate Australian Clinical Trials That Use Unapproved Therapeutic Goods (AUS-86) (Last Updated May 26, 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) Pre-Submission Meetings with TGA (AUS-92) (Last Updated December 2, 2020)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) Review of the Clinical Trial Approval (CTA) Scheme (AUS-88) (Last Updated September 1, 2024)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) Submit Evaluation Information to us Electronically (AUS-94) (Last Updated July 10, 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) Therapeutic Goods Orders (AUS-93) (Last Updated October 1, 2024)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
Sources Revised During this Update:
(Guidance) Fees and Charges: Summary - From 01 July 2025 (G-FeesCharges) (Version 1.0) (July 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Guidance) Preparing for Good Clinical Practice (GCP) Inspections (G-GCP-Inspect) (Last Updated July 2, 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Guidance) The PIC/S Guide to GMP for Medicinal Products – Version 17 (AU-PIC-S-GMP-Guide) (September 1, 2025)
Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) About Us (AUS-32) (Current as of September 30, 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing
(Webpage) Clinical Trials (AUS-47) (Last Updated May 6, 2025)
Therapeutic Goods Administration, Department of Health and Aged Care
(Webpage) What We Regulate (AUS-31) (Current as of September 30, 2025)
Therapeutic Goods Administration, Department of Health, Disability and Ageing