Submitting a Clinical Trial Notification to the TGA

Therapeutic Goods Administration Clinical Trial Notification

The Therapeutic Goods Administration Clinical Trial Notification process is required for trials conducted in Australia that involve the use of an unapproved investigational therapeutic medical product or device. The therapeutic goods legislation requires that the use of therapeutic goods in a clinical trial conducted under the CTN/CTX schemes must be in accordance with:

An investigational medical product, device or biological is defined as follows:

  • any medicine not entered on the Australian Register of Therapeutic Goods (ARTG) or approved for use in the country that the trial is being conducted in. 
  • the use of a new formulation, strength, size, dosage form, name, indications, directions for use or type of container of a medicine already listed in the ARTG or approved for use in the country that the trial is being conducted in.
  • any medical device not entered in the ARTG or approved for use in the country that the trial is being conducted in.
  • any new design specification, model, technology, material or treatment modality of a medical device listed in the ARTG or approved for use in the country that the trial is being conducted in.
  • any biological not entered in the ARTG or approved for use in the country that the trial is being conducted in:
    • including any new applicable standards, intended clinical use or principal manufacturer of a Class 1 or 2 biological already in the ARTG or approved for use in the country that the trial is being conducted in.
    • including any new product name, dosage form, formulation or composition, therapeutic indication, type of container or principal manufacturer of a Class 3 or 4 biological already in the ARTG or approved for use in the country that the trial is being conducted in.

Research Ethics Compliance Support manages the Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) submission portal.

0
Notification Requirements

Before the CTN form can be completed in the TGA portal, the following requirements steps must be followed:

0
Submission Requirements
  • An email to clinicaltrials@unsw.edu.au must be sent to request access to the TGA CTN portal. Access requests must only be sought after the notification requirements have been met.
  • For research conducted by the Black Dog Institute the request is to be sent to the Director Strategy & Operations at BDI n.cockayne@blackdog.org.au.
0
Timeframe for Access
  • Researchers should allow up to 5 working days to receive access.   
0
Clinical Trials Conducted in Other Countries

Where UNSW agrees to be the sponsor of the clinical trial, the Coordinating Principal Investigator is responsible for identifying the relevant regulatory requirements that involve the use of an unapproved therapeutic investigational medical product or device in other countries. Specific details need to be included in the clinical trial protocol.

0