Clinical trials

29 April 2016

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 ).

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

Contact details for enquiries about clinical trials in Australia

If your enquiry is not specifically about clinical trials, see: Contact the TGA

Contact details
Contact method Clinical trials of medicines
Email
Phone
  • 1800 020 653 (freecall within Australia)
  • +61 2 6232 8106

Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:

  • TTY or computer with modem users: phone 1800 555 677 then ask for 1800 020 653
  • Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 020 653
Fax +61 2 6232 8112
Postal address Pharmacovigilance and Special Access Branch
Medicines Regulation Division
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia