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Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme

6 November 2020

The Therapeutic Goods Administration (TGA) has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme.

The name change from CTX to CTA more accurately reflects the nature of the scheme under the Therapeutic Goods Act 1989, which involves sponsors applying for the TGA's approval to supply unapproved therapeutic goods in Australia via a clinical trial despite the therapeutic goods not being entered in the Australian Register of Therapeutic Goods (ARTG). The scheme's previous name of CTX underscored the exemption given by the TGA to a sponsor from entering their therapeutic good in the ARTG before conducting a clinical trial.

Clinical trials conducted in Australia are subject to various regulatory controls to ensure the safety of participants. Under the CTA scheme, as with CTX, sponsors will still need to apply to the TGA and undergo a formal evaluation and approval process for supply of the unapproved therapeutic good via a clinical trial with respect to the safety guidelines for the good's use.

The accompanying Clinical Trial Notification (CTN) scheme remains unchanged whereby any therapeutic goods used in clinical trials do not require evaluation and entry in the ARTG, although the TGA still needs to be notified of the sponsor's intent to conduct a clinical trial involving the unapproved good. The overall decision as to whether a CTN or CTA is required in relation to the use of an unapproved therapeutic good is the responsibility of the trial sponsor. Consultation with a Human Research Ethics Committee (HREC) that will approve the trial protocol may assist in the decision.

The TGA has updated our online information and application forms to reflect this name change from CTX to CTA. For consistency, we ask that relevant agencies and stakeholders also update their own documentation. The names of the clinical trials schemes are not explicitly mentioned in therapeutic goods legislation, so the proposed change will only impact our online information, application forms, and the Australian clinical trial handbook.