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

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

Contact method Clinical trials of medicines
  • 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
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609