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How we regulate Australian clinical trials that use unapproved therapeutic goods

If you plan to run a clinical trial in Australia using an unapproved therapeutic good, you must either:

The CTN and CTA schemes are required to lawfully import or supply an unapproved therapeutic good for experimental purposes in humans in accordance with the Therapeutic Goods Act 1989 - external site.

We inspect clinical trial sites that use unapproved therapeutic goods through our Good Clinical Practice (GCP) Inspection Program.

Unapproved therapeutic goods

An unapproved therapeutic good is any therapeutic good:

Medicines

Medical devices 

(including in vitro diagnostic devices (IVD))

Biologicals

any new:

  • formulation
  • strength or size
  • dosage form
  • name
  • indication
  • direction for use
  • type of container

 

any new:

  • manufacturer
  • device nomenclature system code
  • classification
  • unique product identifier (for certain classes of medical devices)

any in-house IVD where the laboratory providing the in-house IVD cannot comply with the regulatory requirements for in-house IVDs.

Class 1 or 2 biological, any new:

  • applicable standards
  • intended clinical use
  • principal manufacturer

Class 3 or 4 biological, any new:

  • product name
  • dosage form
  • formulation or composition
  • therapeutic indication
  • type of container
  • principal manufacturer

An ARTG entry applies to a specific sponsor (an individual or company). If the same or similar product is imported or supplied by another sponsor it is considered unapproved.

Talk to your HREC (Human Research Ethics Committee)

Before you conduct a clinical trial in Australia, you must consult your HREC to determine if:

  • your study is a clinical trial
  • your study involves an unapproved therapeutic good
  • an exemption under the CTN or CTA scheme is appropriate

We don't give advice on these matters.

You must have HREC approval and a CTN or CTA in place before supplying an unapproved therapeutic good that is part of a clinical trial in Australia. The HREC:

  • provides advice for trial protocol and design
  • weighs the risks and benefits of the therapeutic good
  • determines if your proposed clinical trial is ethical
  • approves the trial protocol
  • monitors the conduct of the trial

For more information on HREC responsibilities, see our Australian clinical trial handbook

When you need a clinical trial supply exemption

  1. You will need a clinical trial supply exemption if you answer yes to all the following questions:
  2. Are you conducting a clinical trial?
  3. Does the clinical trial involve the use of any therapeutic goods?
  4. Are any of the therapeutic goods unapproved?

Which clinical trial supply exemption can you use?

If you have determined that a clinical trial supply exemption is required, you also need to determine which one you can use. The following questions will help you decide whether you should use the CTN or CTA scheme.

  1. Are any of the unapproved therapeutic goods in your trial a class 4 biological?
            - No – CTA is not mandatory, and your trial is eligible for either scheme.
            - Yes – CTA may be mandatory. See question 2.
  2. Does at least one of the following conditions (a. and b.) apply?
    1. Evidence from previous clinical use supports the use of the biological. For example, the safety of the product has been evaluated in an earlier phase clinical trial. The effect on safety of changes in the manufacture of the product, or of use of the product for a new clinical indication, must be carefully considered.
    2. A national regulatory body with comparable regulatory requirements has approved a clinical trial for an equivalent indication. Seek advice from us if you intend to use this provision. You will need to provide evidence that the safety review by the overseas regulator is equivalent to that which would be performed by us. In addition, the product used in the trial approved by the overseas regulator must be the same as that in the proposed trial. The effect on safety of changes in the manufacture of the product, or of use of the product for a new clinical indication, must be carefully considered.
      - No – The CTA scheme is mandatory for your trial.
      - Yes – CTA is not mandatory, and your trial is eligible for either scheme.

The choice of which scheme to use (CTN or CTA) lies firstly with the trial sponsor and then with the HREC that approves the protocol. The scheme you choose must be based on whether the trial falls under the mandatory requirements of the therapeutic goods legislation. If your trial is eligible for either scheme, the HREC will consider whether the committee has access to appropriate scientific and technical expertise to assess the safety of the product.

Good Clinical Practice (GCP) Inspection Program

We inspect Australian clinical trial sites regulated under the CTN or CTA schemes. Our GCP Inspectors visit the site of your clinical trial and evaluate the effectiveness of your systems and procedures. 

Inspectors ensure that the use of the unapproved therapeutic good is in accordance with:

You must also comply with:

  • any other Commonwealth, state and territory clinical trials legislation 
  • any requirements for the import, export, manufacture, and supply of therapeutic goods in Australia.

Find out how we inspect clinical trial sites under the Good Clinical Practice (GCP) Inspection Program.

 

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