We do not evaluate any data about the clinical trial at the time of notification.
The CTN pathway is most appropriate when the requirements of the Clinical Trial Approval (CTA) scheme do not apply.
For step-by-step guidance on how to submit a CTN, read the Clinical trial notification (CTN) form - user guide.
For information on fees to submit a CTN, read Summary of fees and charges to applications submitted to the TGA.
Before you submit
- Determine if your trial is eligible to be conducted under the CTN scheme.
- If eligible for the CTN and CTA schemes, discuss the appropriateness of the CTN scheme with your approving Human Research Ethics Committee (HREC). Download a list of Human Research Ethics Committees (HRECs) registered with NHMRC.
- Decide if you should upload an Investigator's Brochure (IB) with your CTN. See Investigator’s brochures for medical device clinical trials.
- Know your responsibilities. See the Australian clinical trial handbook.
- Read the CTN Declaration on page 50 of the Clinical trial notification (CTN) form – user guide.
Submit a CTN
A CTN is submitted by the Australian clinical trial sponsor. You will need a client identification number. See TGA Business Services: getting started with the TGA.
- To submit a CTN, follow the steps in the CTN form user guide and pay the fee.
Make a variation to your CTN
Variations may arise over the course of the clinical trial, the Australian clinical trial sponsor needs to submit a variation to let us know of any changes to the details provided in the CTN form.
Some changes incur a fee. These include:
- addition of a new site to a trial
- change to the notified therapeutic good that creates a separate and distinct good
- addition of a new therapeutic good to a previously notified trial.
To submit a CTN variation, follow the steps in the CTN form user guide and pay the fee (if required).
Notify us when clinical trial ends
When you finish your clinical trial, you should tell us. You should do this when you no longer need the CTN exemption for your trial activities.
You don't need to tell us when each individual site completes the trial. Wait until your trial ends at all sites.
There is no fee to submit a CTN completion.
To submit a CTN completion, follow the steps in the Clinical trial notification (CTN) form - user guide.
When can you supply the therapeutic good
You cannot supply the therapeutic good unless you have submitted the CTN and paid the appropriate fee.
Alongside the CTN submission, you need approval from:
- The Human Research Ethics Committee (HREC)
- The institution or organisation where the trial will be carried out (Approving Authority)
It is the responsibility of the Australian clinical trial sponsor to have all relevant approvals in place. You must do this before supplying the unapproved therapeutic good in the clinical trial. You do not need our CTN acknowledgement before your trial can begin recruiting.
Some HRECs and Approving Authorities may need our acknowledgement before beginning their own approval process. In these cases, we will accept a CTN submission while you get the required approvals from the HREC and Approving Authority.
The CTN scheme notifies the Secretary about a clinical trial using an 'unapproved' therapeutic good to be used solely for experimental purposes humans. This is pursuant to the exemption under Section 18(1), 32CA (2) and 41HA of the Therapeutic Goods Act 1989.
Once the requirements set out under Item 3 of Schedule 5A of the Therapeutic Goods Regulations 1990 and Item 2.3 of Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002 have been met (that is submission of the online CTN form with payment of the relevant fee to the TGA), the clinical trial is deemed to have been notified.
Once this occurs, the exemption under Section 18(1), 32CA(2) and 41HA of the Therapeutic Goods Act 1989 comes into effect, and you can lawfully supply the unapproved therapeutic good(s) for the purposes of the trial.
Get help
If you need help with your CTN, email us at clinical.trials@health.gov.au.