ICH Guideline for Good Clinical Practice - Australian Government


You will need to comply with this guideline if you intend to conduct an approved clinical trial.

This guideline is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. Please note that these standards may be overridden by national legal requirements and the requirements of individual regulatory agencies.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

Service type

Advisory Material

Advisory material provides advice and guidance in undertaking a business.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Please use these contact details for help or more information:


Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)