Clinical trials

1 July 2015

New online form for CTN scheme

A new online form is now available for the clinical trial notification (CTN) scheme, which is the first in a series of developments to improve and streamline the administrative processes of the clinical trial schemes.

Clinical trials sponsors can now submit a notification via the TGA Business Services (TBS) site. Guidance material for the online CTN form is available at CTN scheme forms.

We encourage you to provide feedback on your experiences with the online CTN form, which will help to continually improve the new format.

Please note: The paper-based notification form will no longer be available, as there are some differences in the required information for the new online form. Any paper based forms we receive after the 1st of July will also need to be submitted online via TBS, and we will work with affected clinical trial sponsors during this initial transition period.

Further information

We have also updated the clinical trials frequently asked questions (FAQs) to include information on the new online CTN form.

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

Notes for guidance on clinical trials

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

TGA contact details
Contact method Clinical trials of medicines
Email clinical.trials@tga.gov.au
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 Scientific Evaluation and Special Product Access Branch
Market Authorisation 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