Australia Profile Updated
The Australia profile in ClinRegs has been updated with the following information, which is current as of February 5, 2025:
- Investigational product requirements from the Therapeutic Goods Administration (TGA)’s 2024 adoption of the 2022 PIC/S guide to good manufacturing practice (See Manufacturing & Import, Quality Requirements, and Product Management)
- Additional details related to Clinical Trials Notifications (CTN) from the 2024 CTN form user guide (See Regulatory Fees, Submission Content, and Manufacturing & Import)
- 2024 TGA guidance on preparing for good clinical practice inspections (See Scope of Assessment and Risk & Quality Management)
- References to international scientific guidelines adopted by the TGA (See Regulatory Authority, Progress Reporting, Site/Investigator Selection, Risk & Quality Management, Data & Records Management, Children/Minors)
Sources Added During this Update:
(Document) GMP Requirements for Medicinal Products: PIC/S Guide to GMP PE009-16 (AUS-73) (Version 1.0) (June 2024)
Therapeutic Goods Administration, Department of Health and Aged Care
(International Guidance) Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products - Guidance for Industry (AUS-83) (Adopted by the TGA February 27, 2023)
Food & Drug Administration, US Department of Health & Human Services
(International Guidance) Guideline on Clinical Trials in Small Populations (AUS-79) (Overseas Effective Date February 1, 2007)
European Medicines Agency
(International Guidance) Guideline on Data Monitoring Committees (AUS-78) (Overseas Effective Date January 2006)
European Medicines Agency
(International Guidance) Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products (AUS-77) (Overseas Effective Date September 1, 2007)
European Medicines Agency
(International Guidance) Guideline on the Content, Management and Archiving of the Clinical Master File (Paper and/or Electronic) (AUS-75) (Adopted by the TGA July 15, 2019)
European Medicines Agency
(International Guidance) ICH E11(R1) Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population (AUS-80) (Adopted by the TGA June 26, 2024)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) ICH Guideline E8 (R1) on General Considerations for Clinical Studies (AUS-76) (Adopted by the TGA June 26, 2024)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) ICH Topic E 3: Structure and Content of Clinical Study Reports (AUS-81) (Overseas Effective Date July 1996)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) ICH Topic E 9 - Statistical Principles for Clinical Trials (AUS-85) (Overseas Effective Date September 1998)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) ICH Topic E 10 Choice of Control Group in Clinical Trials (AUS-84) (Overseas Effective Date January 2001)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) Use of Electronic Health Record Data in Clinical Investigations - Guidance for Industry (AUS-82) (Adopted by the TGA February 27, 2023)
U.S. Food & Drug Administration, U.S. Department of Health & Human Services
(Webpage) International Scientific Guidelines Adopted in Australia (AUS-74) (Current as of February 5, 2025)
Therapeutic Goods Administration, Department of Health and Aged Care
Sources Revised During this Update:
(Legislation) Privacy Act 1988 (No. 119, 1988, Compilation No. 101) (PrivacyAct) (Amended December 11, 2024)
Office of Parliamentary Counsel
(Guidance) Australian Clinical Trial Handbook: Guidance on Conducting Clinical Trials in Australia Using ‘Unapproved’ Therapeutic Goods (G-CTHandbook) (Last Updated October 3, 2024)
Therapeutic Goods Administration, Department of Health and Aged Care
(Guidance) Fees and Charges: Summary - From 01 January 2025 (G-FeesCharges) (Version 2.0) (January 2025)
Therapeutic Goods Administration, Department of Health and Aged Care
(Guidance) ICH Guideline for Good Clinical Practice, Annotated with TGA Comments (AU-ICH-GCPs) (Last Updated January 17, 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Therapeutic Goods Administration, Department of Health and Aged Care
(Guidance) PIC/S Guide to GMP for Medicinal Products – Version 16 (AU-PIC-S-GMP-Guide) (March 1, 2024)
Therapeutic Goods Administration, Department of Health and Aged Care
(Guidance) Preparing for Good Clinical Practice (GCP) Inspections (G-GCP-Inspect) (Last Updated November 4, 2024)
Therapeutic Goods Administration, Department of Health and Aged Care
(Document) National Certification Scheme: Institutions with Certified Ethics Review Processes (AUS-68) (Last Updated January 9, 2025)
National Health and Medical Research Council
(Document) Clinical Trial Notification (CTN) Form - User Guide (AUS-49) (Version 1.4) (May 2024)
Therapeutic Goods Administration, Department of Health and Aged Care
(Webpage) Corporate Structure (AUS-28) (Last Updated January 29, 2025)
Therapeutic Goods Administration, Department of Health and Aged Care
(Webpage) Payment Options (AUS-66) (Last Updated July 18, 2024)
Therapeutic Goods Administration, Department of Health and Aged Care