Clinical trials
There are two schemes under which clinical trials involving therapeutic goods may be conducted in Australia: the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme.
If you have an enquiry about clinical trials that is not answered by this website, please see the contact details below.
Clinical trials in Australia
- Access to unapproved therapeutic goods - Clinical trials in Australia
- Australian clinical trial handbook
- Clinical trials at a glance
- Clinical trials FAQs
- Consumer guide to clinical trials
- Human Research Ethics Committees and the therapeutic goods legislation
Notes for guidance on clinical trials
- Note for guidance on clinical safety data management: definitions and standards for expedited reporting
- Note for guidance on good clinical practice
Clinical trials forms
Contact details for enquiries about clinical trials in Australia
If your enquiry is not specifically about product clinical trials, see: Contact the TGA
| Contact method | Clinical trials of medicines | Clinical trials of medical devices |
|---|---|---|
| eps@tga.gov.au | devices@tga.gov.au | |
| Phone |
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
|
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
|
| Fax | +61 2 6232 8112 | +61 2 6232 8785 |
| Postal address | Office of Scientific Evaluation Market Authorisation Group Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia |
Office of Devices Authorisation Market Authorisation Group Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia |
| Street address (for deliveries) |
Therapeutic Goods Administration 136 Narrabundah Lane Symonston ACT 2609 Australia |
Therapeutic Goods Administration 136 Narrabundah Lane Symonston ACT 2609 Australia |
Web page last updated: Wednesday, 7 March 2012
URL: http://www.tga.gov.au/industry/clinical-trials.htm