Are you using a new unapproved drug or device?

The Therapeutic Goods Administration (TGA) provides a legislated regulatory framework for the availability of medicines, medical devices and biologicals within Australia. 

If your clinical trial is using a drug or device that is not yet licenced in Australia, then your Sponsor must also seek approval from the TGA.

The TGA must be notified by the clinical trial Sponsor of the intent to sponsor a clinical trial involving an ‘unapproved’ therapeutic good, medical device or biological. This must be done prior to starting to use the goods at the site.

The CTA and CTN schemes provide for the lawful importation into and/or supply in Australia of ‘unapproved’ therapeutic goods (drug and devices) for use in a clinical trial.

· The TGA CTN Scheme requires the Australian clinical trial sponsor to notify the TGA of the intent to sponsor a clinical trial involving an ‘unapproved’ therapeutic good before starting to use the goods. The notification form must be submitted online and accompanied by the relevant fee.

The TGA CTA Scheme requires the sponsor to submit an application and relevant fee to the TGA seeking approval to supply ‘unapproved’ therapeutic goods in a clinical trial.

If your public health organisation is the Sponsor of your clinical trial it is the responsibility of the organisation to ensure that all relevant approvals are in place before supplying the ‘unapproved’ therapeutic goods in the clinical trial.