TGA (Australia) renames clinical trials CTX scheme to CTA scheme

The TGA has renamed the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme.

  • The change 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 ARTG register.
  • 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 prior to conducting a clinical trial.
  • Like the CTX scheme, under the  CTA scheme, 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 whether a CTN or CTA is required for an unapproved therapeutic good is the responsibility of the trial sponsor. Consultation with a Human Research Ethics Committee (HREC) responsible for approving the trial protocol may assist in the decision making process.
  • The TGA online information and application forms have been updated to reflect this name change from CTX to CTA and for the sake of consistency,  requests relevant agencies and stakeholders to update their own documentation to reflect the change.

Further information is available on the TGA website here.