FAQs on CTN online submissions and the clinical trials scheme

Access to unapproved therapeutic goods

29 April 2016
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To submit CTNs online, you will need access to our secure online TGA Business Services (TBS) site. This applies to organisations that already have a TGA client identification number (Client ID), as well as new organisations.

If your organisation:

  • already has online access to TBS - please see your administrator to arrange user access.
  • has a Client ID without online access to TBS - please nominate an administrator via the Organisation details form to gain access to TBS.
  • does not have a Client ID - go to TGA Business Services: Getting started with the TGA for information and forms to obtain a New Client ID and online access to TBS.

Clinical trials sponsors may wish to seek information regarding the framework for user access; please refer to the table under 'Roles: what each user can do' for information on user roles and individual capabilities in TBS.

Additional information for using the TBS site can be found at TGA Business Services - How to use the site, and any further questions can be directed to the TBS Helpdesk at or 1800 010 624.

The TGA has provided step-by step guidance material on Using the online CTN Form and Completing the online CTN form.

If you experience a system error while using the online form, please advise the clinical trials team via email at or call 02 6232 8106.

Once you have submitted your CTN online, an invoice will be generated. You can then make payment against this invoice. The TGA is aware that the online system does not currently generate an invoice for variations to an online submission. The TGA is working to upgrade this feature as a priority.

Information on payment options can be found on the TGA Payment options webpage.

Yes, variations to trial details can be updated.

You can make variations to a CTN that has been submitted online.

See the Varying trial details section of the Using the online CTN form guidance page.

Please note that certain variations to an existing CTN may incur a fee. The following variations to a previously notified trial will incur a fee:

  • addition of site(s) to a previously notified trial
  • change of site address for a previously notified site
  • change to previously notified therapeutic goods that creates separate and distinct goods
  • addition of a new therapeutic good to a previously notified trial

If you are making a variation that incurs a fee, payments may be made as per the information on the TGA Payment options webpage.

Only the most recent version of the processed CTN can be seen in the 'Clinical Trials Repository'. Older versions are archived in a TGA database.

For more information see the view active and closed clinical trials section of the Using the online CTN form guidance page.

The TGA will continue to provide acknowledgement letters for first-time notification of a clinical trial, addition of a trial site, and changes to therapeutic goods previously notified. The TGA sends the acknowledgement letter via email to the contact person listed on the online CTN Form.

No.

Original signatures are no longer required for a CTN, and have been replaced by an online sponsor declaration.

Under the previous paper-based system, sponsors were required to obtain and submit to the TGA original signatures from the Principal Investigator, Approving Authority and Human Research Ethics Committee. Under the online submission process the TGA does not require the original signatures. However, we require a sponsor declaration acknowledging that the requirements of the Therapeutic Goods legislation are complied with. The sponsor must still ensure the relevant approvals are in place before commencement of the trial and use of the therapeutic goods.

The legislation underpinning the CTN application process has not changed and requires that the trial be run with appropriate governance in place and in accordance with the Guidelines for Clinical Practice (GCP). Section 8.2 of these guidelines outlines the documents and signed agreements that should be on file before the clinical phase of the trial commences. The TGA advises that all parties are in agreement as to when the CTN form should be submitted.

As defined in the Regulations, the clinical trial sponsor must acknowledge that the goods only remain exempt so long as:

The TGA has no issues with the submission of the CTN form while the sponsor is obtaining the necessary endorsements. However, it is the responsibility of the sponsor to ensure that all relevant approvals are in place before supplying the therapeutic goods in the clinical trial.

No. The TGA will continue to process CTX applications under the clinical trials scheme using the paper-based process. CTX forms are available on the TGA website. The new online system is currently only available for the CTN scheme.

You do not have to wait for an acknowledgment letter from us before supplying the unapproved goods. As soon as the requirements set out under Item 3 of Schedule 5A of the Therapeutic Goods Regulations 1990 (the Regulations) have been met (i.e. 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) of the Therapeutic Goods Act 1989 (the Act) comes into effect, and the sponsor can supply the goods.

The notification to the TGA of trial completion can be done once the clinical trial-related activity afforded by a CTN exemption is no longer required. It is however up to the sponsor to determine when the exemption is no longer required. Notification of completion of a clinical trial should be made only after the trial has been completed at all sites. It is not necessary to notify completion dates for individual trial sites.

Please note that notification of trial completion must now be done via the new online form. Please refer to the Using the online CTN form guidance document.

The sponsor must be an Australian entity (see Does the sponsor of a clinical trial in Australia have to be an Australian entity?).

Clinical trials can be sponsored by:

  • individuals (for example, medical practitioners)
  • bodies and organisations (for example, hospitals, Area Health Services, non-government organisations)
  • companies (for example, pharmaceutical companies).

The type of sponsor will vary from trial to trial, depending on who takes overall responsibility for the conduct of the trial.

The sponsor usually initiates, organises and supports a clinical study, and carries the medico-legal responsibility associated with the conduct of the trial.

If the investigator initiates and organises the trial, he or she is to be defined as the sponsor of the trial and will be responsible for the sponsor's functions. This includes, for example, where another party (usually a pharmaceutical company) provides the medicinal product used in the clinical trial, but has no other involvement in the conduct of the trial.

Yes.

An overseas company or person or entity, for the purpose of the Australian legislation, is not the 'sponsor' of the trial in Australia.

The general responsibilities of sponsors of clinical trials are set out in section 5 of the CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). The sponsor must also fulfil all regulatory requirements of the TGA and comply with State and Territory legislation in relation to the supply of therapeutic goods.

The sponsor is also responsible for establishing legal and financial agreements between the sponsor, investigators and participating institutions/organisations. These should address issues such as indemnity of the parties involved in the trial and compensation and treatment of trial participants in the case of injury or death.

The TGA has adopted the PIC/S Guide for Good Manufacturing Practice for Medicinal Products 2009, with Annex 13 of this guide referring to the manufacture of investigational medicinal products. Labelling requirements are outlined under items 26-33.

The Clinical Trials Notification (CTN) and Clinical Trials Exemption (CTX) schemes provide two avenues through which 'unapproved therapeutic goods' may be lawfully supplied for use solely for experimental purposes in humans. An 'unapproved therapeutic good' includes:

  • any medicine not entered on the ARTG, including any new formulation, strength or size, dosage form, name, indications, directions for use or type of container of a medicine already in the ARTG.
  • any medical device not entered in the ARTG, including any new design specification, model, technology, material or treatment modality of a medical device already in the ARTG.
  • any biological not entered in the ARTG:
    • including any new applicable standards, intended clinical use or principal manufacturer of a Class 1 or 2 biological already in the ARTG.
    • including any new product name, dosage form, formulation or composition, therapeutic indication, type of container or principal manufacturer of a Class 3 or 4 biological already in the ARTG.
  • a therapeutic good already in the ARTG that is used beyond the conditions of its marketing approval including labelling.

The choice of which route to use (CTN or CTX) lies firstly with the sponsor and then with the Human Research Ethics Committee (HREC) that reviews the protocol.

The current fees for clinical trials can be found on the TGA Schedule of fees and charges.

Applications for clinical trials under the CTX scheme cost more than notifications under the CTN, which reflects the increased work needed to evaluate the data in a CTX application. There is a single fee for CTX that includes both Parts 1 and 2.

It is important to appreciate that the TGA cannot treat subgroups of trialists differently according to their ability to pay.

CTN scheme

Please note that certain variations to an existing CTN may incur a fee. The following variations to a previously notified trial will incur a fee:

  • addition of site(s) to a previously notified trial
  • change of site address for a previously notified site
  • change to previously notified therapeutic goods that creates separate and distinct goods
  • addition of a new therapeutic good to a previously notified trial