Clinical Trials Notification Scheme transitions to online submission
The Clinical Trials Notification (CTN) Scheme transitioned from a paper-based submission form to online submission on 1 July 2015.
The online CTN form is now accessed via our TGA Business Services website. To find out how to obtain access please go to TGA Business services: getting started with the TGA. You can learn how to use the new online form by referring to the following guidance documents:
The TGA is currently migrating trials that were notified before 1 July 2015, using the paper-based form, to the new online system. The TGA has contacted all clinical trial sponsors via email asking them to confirm the relevant TGA Client ID(s) and list of clinical trials to migrate. If your organisation has current trials that were notified before 1 July 2015, please ensure that your TGA Business Services Administrator responds to this email (via firstname.lastname@example.org).
We have also updated the Clinical trials frequently asked questions (FAQs) to include answers to common enquiries about the new online system and the CTN scheme. An overview of the clinical trials schemes can also be found at Clinical trials at a glance.
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 forms
Clinical trials in Australia
Guidance on clinical trials
- Access to unapproved therapeutic goods - Clinical trials in Australia
- Australian clinical trial handbook
- Clinical trials: information for consumers
- Human Research Ethics Committees and the therapeutic goods legislation
- Note for guidance on clinical safety data management: definitions and standards for expedited reporting
- Note for guidance on good clinical practice
Contact details for enquiries about clinical trials in Australia
If your enquiry is not specifically about clinical trials, see: Contact the TGA
|Contact method||Clinical trials of medicines|
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
|Fax||+61 2 6232 8112|
|Postal address||Pharmacovigilance and Special Access Branch
Medicines Regulation Division
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
|Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609