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How to start a trial in Australia? * Regulatory Approval


Australian legal entity

The sponsor of a clinical trial in Australia must be an Australian legal entity. Most local Clinical Research Organisations (CROs) can make arrangements to act as the Australian sponsor of a clinical trial if the overseas sponsor does not have an Australian affiliate to fulfil this role.

In Australia there are two routes that may be taken to gain regulatory approval to conduct a trial - the Clinical Trial Exemption (CTX) and Clinical Trial Notification (CTN) schemes.

These schemes are used for clinical trials involving: 

Clinical trials in which registered or listed medicines or medical devices are used within the conditions of their marketing approval are not subject to CTN or CTX requirements however, they still need to be approved by a Human Research Ethics Committee (HREC) before the trial may commence.

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CTN is a notification scheme and over 95% of all trials are approved via this route. Via this route the onus is on the HREC to bear the responsibility for approving:

  • the safety and efficacy of the medicine or device; 
  • the ethical acceptability of the trial process; 
  • approval of the trial protocol; and 
  • evaluating the scientific merit of the trial.

The TGA does not review any data relating to the clinical trial but simply acknowledges the trial in writing within 10 days of receipt of the signed CTN form and appropriate payment.

A separate CTN form must be completed for each potential trial site. It is standard for all fees to be reimbursed to the CRO by the sponsor as part of the trial budget. CTN trials cannot commence until the trial has been notified to the TGA and the appropriate notification fee paid.

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CTX is a modified approval process by which a sponsor submits an application to conduct a clinical trial to the TGA for evaluation and comment. A TGA delegate decides whether or not to object to the proposed usage guidelines for the product. If an objection is raised, trials may not proceed until the objection has been addressed to the delegate’s satisfaction.

If no objection is raised, the sponsor may conduct any number of clinical trials under the CTX application without further assessment by the TGA, provided that use of the product in the trials falls within the original approved usage guidelines. Each trial conducted must be notified to the TGA.

A sponsor cannot commence a CTX trial until written advice has been received from the TGA regarding the application and approval for the conduct of the trial has been obtained from a HREC at each institution where the trial will be conducted. Two forms, each reflecting these separate processes (Parts), must be submitted to the TGA by the sponsor:

  • Part 1 constitutes the formal CTX application. It must be completed by the sponsor of the trial and submitted to TGA with data for evaluation. 
  • Part 2 is used to notify the commencement of each new trial conducted under the CTX as well as new sites in ongoing CTX trials. This Part 2 form must be submitted within 28 days of the commencement of supply of goods under the CTX.

The CTX approach is rarely used in Australia.

Human gene therapy research proposals may also be considered, on request from either the HREC or TGA by the Cellular Therapies Advisory Committe in order to assess the suitability of the research to be undertaken using the CTN Scheme.

Clinical trials in which registered or listed medicines or medical devices are used within the conditions of their marketing approval are not subject to CTN or CTX requirements but still need to be approved by a HREC before the trial may commence.

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Fees for the regulatory approval of clinical trials

As of 1 July 2007, TGA fees for the CTN Scheme are AUD$250 for each notification. A notification can be made for all sites participating in the trial simultaneously or several notifications can be made for subgroups of sites. A notification fee applies for each single notification.

The fee for a CTX 50 day review is AUD$15,300 (review of chemical, pharmaceutical and biological, pharmaco-toxicological and clinical data). The fee for a 30 day review is AUD$1,240.

CTX 30 Days - AUD$ 1,240
CTX 50 Days - AUD$ 15,300
CTN (one trialling body) - AUD$ 250
CTN (more than one trialling body) - AUD$ 250

Click here to view a summary of the TGA fees and charges as at 1 July 2007.

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Standard Clinical Trial Agreement in Queensland

Queensland Health has developed a Standard Clinical Trial Agreement to be used for all Clinical Trials involving Queensland Health sites, facilities, staff or patients, together with a User Guide.

There are two types of the QH Clinical Trial Agreement (QH CTA): 

  • The first version ‘A’ is designed to be used when the parties are the State of Queensland (Queensland Health) and a Sponsor e.g. industry / pharmaceutical company;
  • The second version ‘B’ is designed to be used where a Clinical Research Organisation (CRO) is acting on behalf of the Sponsor to make arrangements and manage the clinical trial. Both the Sponsor and CRO must be party to this Agreement.

Visit Queensland Health for more information.

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