ICH Guideline for Good Clinical Practice - AG - Australian Business Licence and Information Service

Description

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.

Service type

Advisory Material

Advisory material provides advice and guidance in undertaking a business.

Other resources

Task	Business Structure	Resources
Comply	All	ICH Harmonised Guideline - Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) - PDF (Opens in new window)

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

**Please use these contact details for help or more information:**

Enquiries

Therapeutic Goods Administration

Department of Health and Aged Care
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)

Supporting information

ICH Guideline for Good Clinical Practice (Opens in new window)

ICH Guideline for Good Clinical Practice - Australian Government