Australia Profile Updated in ClinRegs

December 17, 2021

The Australia profile in ClinRegs has been reviewed and updated to ensure all information and sources are up-to-date and accurate. While there were no substantial edits to the summary text, some sources were added to the profile to provide supplementary information.

Sources Added During this Update:

(Webpage) Australian Clinical Trial Sites (AUS-62) (Current as of December 16, 2021)
National Health and Medical Research Council and Department of Industry, Innovation and Science

(Webpage) Australian Clinical Trials - For Researchers (AUS-64) (Last Updated September 13, 2021)
National Health and Medical Research Council and Department of Industry, Innovation and Science

(Webpage) How to Talk to Potential Participants (AUS-65) (Last Updated February 19, 2015)
National Health and Medical Research Council and Department of Industry, Innovation and Science

(Webpage) The Department of Health - Clinical Trials (AUS-61) (Last Updated September 15, 2021)
Department of Health

(Webpage) Australian Commission on Safety and Quality in Health Care - Clinical Trials (AUS-63) (Current as of December 16, 2021)
Australian Commission on Safety and Quality in Health Care

(Webpage) Payment Options (AUS-66) (Last Updated March 7, 2017)
Therapeutic Goods Administration, Department of Health

Sources Revised During this Update:

(Guidance) Australian Clinical Trial Handbook: Guidance on Conducting Clinical Trials in Australia Using ‘Unapproved’ Therapeutic Goods (G-CTHandbook) (Version 2.4) (August 2021)
Therapeutic Goods Administration, Department of Health

(Guidance) Fees and Charges: Summary from 1 December 2021 (G-FeesCharges) (Version 2.0) (November 2021)
Therapeutic Goods Administration, Department of Health

(Legislation) Privacy Act 1988 (No. 119, 1988, Compilation No. 84) (PrivacyAct) (Amended September 4, 2021)
Office of Parliamentary Counsel

(Legislation) Therapeutic Goods (Manufacturing Principles) Determination 2020 (TGManuf) (September 30, 2021)
Office of Parliamentary Counsel

(Legislation) Therapeutic Goods Act 1989 (No. 21, 1990, Compilation No. 77) (TGAct) (Amended September 1, 2021)
Office of Parliamentary Counsel

(Legislation) Therapeutic Goods Regulations 1990 (Statutory Rules No. 394, 1990, Compilation No. 96) (TGR) (Amended October 29, 2021)
Office of Parliamentary Counsel

(Document) Research Governance Policy (AUS-5) (June 8, 2021)
Department of Health, Government of Western Australia

(Webpage) Clinical Trials (AUS-47) (Last Updated December 6, 2021)
Therapeutic Goods Administration, Department of Health