Clinical trials

13 October 2015
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Migration of Clinical Trial Notifications (CTNs) from paper-based database to new online system

The CTN Scheme is undergoing a series of improvements to streamline administrative processes.

Ongoing improvements will be implemented in stages.

The TGA will need to migrate CTN information from trials that were notified via the paper-based system to the online TBS system. Once completed, this will allow sponsors to use the TBS system to view and change active CTNs that were notified before 1 July 2015.

What you need to do:

  • ensure that your organisation does not have duplicate TGA client IDs
  • ensure that your organisation has online access to TGA Business Services (TBS)
  • nominate an administrator for your organisation and ensure all users have appropriate system user roles and access
  • if your organisation decides to change client ID please inform the clinical trials team via email at by 7 December 2015.
Migration stages

Stage 1: Closing of paper-based database on 19 October 2015

Stage 2: Data re-formatting

Stage 3: From 7 December 2015, posting re-formatted data onto TBS system

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.

To submit CTNs online, you will need access to our secure online TGA Business Services (TBS). To find out how to obtain access please go to TGA Business Services - How to use the site.

Guidance material on how to use 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.

New transition form for changes to clinical trial notifications (CTNs)

A transition form is now available to notify the TGA of changes to a Clinical Trial notified to the TGA under the Clinical Trial Notification (CTN) scheme prior to 1 July 2015, for example the notification of one or more additional sites.

Note that this form cannot be used for:

  • Changes to a clinical trial notified on or after 1 July 2015.

    Changes would need to be made online to the previously acknowledged trial.

  • Changes which render the therapeutic goods separate and distinct from the previously notified goods, for example a change in dosage form.
  • The addition of a new therapeutic good to a previously notified trial.

    A change to a therapeutic good that renders the good as separate and distinct from the previously notified goods and the addition of a new therapeutic good to a previously notified trial will require the sponsor to submit a new CTN. Section 16 of the Therapeutic Goods Act 1989 (the Act) lists the criteria which make goods separate and distinct.

  • Notification of a new clinical trial.

    A new CTN should be submitted using the online form available on the TGA website.

    The transition form can be downloaded from the CTN forms webpage.

Further information

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

Contact details
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 Pharmacovigilance and Special Access Branch
Medicines Regulation Division
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609