Which clinical trial scheme should I choose?

This material is provided by the TGA (a part of the Department of Health) solely to provide a general overview of the TGA regulatory scheme, and particularly to assist small to medium enterprises to better engage with the regulatory scheme. It should not be taken as a detailed description of the scheme or as specific advice on the application of the therapeutic goods legislation in particular cases, nor as a statement of policy.

If you would like further information you should contact the TGA (the TGA website also contains more detailed information on all aspects of the regulatory scheme), or if you need advice on the application of the therapeutic goods legislation in particular cases, you should make your own enquiries to obtain that specific advice.

The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials.

These materials are based on the scheme as at 10 April 2018.

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The trial sponsor must first determine whether any of the products to be used in a clinical trial meet the definition of a 'therapeutic good'.

Use our online tool, Is my product a therapeutic good?, to help determine if a particular product is a therapeutic good, and if so, what type. Also see our guidance, What are ‘therapeutic goods’?

Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before those goods can be lawfully imported into, exported from, or supplied in Australia unless otherwise the subject of an exemption, approval or authority under the Therapeutic Goods Act 1989.

However, the CTN and CTA schemes provide for the lawful importation into and/or supply in Australia of 'unapproved' therapeutic goods for use in a clinical trial.

How to determine if your product is unapproved

Our guidance Determine if the product is ‘unapproved’ may be used to help decide whether any of the therapeutic goods (not just the investigational product or main product of interest) used in your clinical trial are considered to be 'unapproved'.

If you are using an 'unapproved' therapeutic good in a clinical trial that is not otherwise subject to an exemption you must notify the TGA through the CTN or CTA schemes.

The trial sponsor must identify the type(s) of therapeutic good(s) used in the trial in a CTN or CTA submission. 

The 'Determine the type of therapeutic good' webpage provides guidance on the different types of therapeutic goods.

Class 4 biologicals

Biologicals are grouped into four classes. The CTA scheme is mandatory for clinical trials involving certain Class 4 biologicals. The Therapeutic Goods Regulations 1990 and the Australian regulatory guidelines for biologicals (ARGB) specify what a Class 4 biological is.

Under the biologicals regulatory framework, the CTA scheme is mandatory for a clinical trial involving a Class 4 biological unless the use of the biological is:

• supported by evidence from previous clinical use, or
• approved for clinical trial use by a comparable overseas regulator for an equivalent indication. Seek advice from us if you intend to use this provision.

For more information, see Choosing between the CTN and CTA schemes.

The main difference between the CTN and CTA schemes is the CTN is a notification scheme while the CTA is an evaluation process.

The choice of which scheme to use (CTN or CTA) lies firstly with the trial sponsor and then with the Human Research Ethics Committee (HREC) that approves the protocol. 

A list of all HRECs registered with the NHMRC is available on the NHMRC website. For further information see Role of Human Research Ethics Committees (HRECs).

Clinical trials that do not involve ‘unapproved’ therapeutic goods are not subject to CTN or CTA requirements. However, all clinical trials need to be approved by a Human Research Ethics Committee (HREC) before they can start.

Useful links

• Australian clinical trial handbook
• Human Research Ethics Committees (HRECs)

A CTA application is required. See the CTA scheme for further information.

Clinical trials conducted under the CTA scheme must also be approved by the responsible Human Research Ethics Committee (HREC).

Useful links

• Australian clinical trial handbook
• Clinical trials
• Human Research Ethics Committees (HRECs)

The therapeutic goods legislation requires that the use of the goods must be in accordance with the protocol approved by the HREC for both the CTN and CTA schemes. 

One of the determining factors for a HREC is whether the committee has access to appropriate scientific and technical expertise in order to assess the safety of the product. 

See Choosing between the CTN and CTA schemes for further guidance on deciding between the schemes.

Useful links

• HRECs and the therapeutic goods legislation
• The CTN and CTA schemes
• Australian clinical trial handbook
• Human Research Ethics Committees (HRECs)
• Clinical trials

Upon consultation with the HREC, you may be able to use the CTN or CTA schemes.

One of the determining factors for a HREC is whether the committee has access to appropriate scientific and technical expertise in order to assess the safety of the product.

See the 'Choosing between the CTN and CTA schemes' webpage for further guidance on deciding between the schemes.

Useful links

• Clinical trials overview
• Australian clinical trial handbook: CTN and CTA schemes
• Australian clinical trial handbook