Clinical trials are highly regulated in Australia and are subject to various Regulatory controls to ensure the safety of participants. Clinical trials of medicines and biologicals are regulated under the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes.
CTN and CTA schemes apply when the ‘unapproved’ therapeutic good to be used in the clinical trial has to be imported into and/or supplied in Australia. Clinical trials that don’t require 'unapproved' therapeutic goods are not subject to the requirements of the CTN or CTA schemes.
The CTN Scheme is a notification process that involves the following:
- The sponsor must notify the Therapeutic Goods Administration (TGA) seeking approval to supply ‘unapproved’ therapeutic goods. This process must be done prior to the goods’ usage. For this, the online application form must be submitted along with the fees.
- TGA can further demand specified information relating to the goods.
- The Human Research Ethics Committee (HREC) reviews the scientific validity of the trial design, the balance of risk versus harm of the therapeutic good, the ethical acceptability of the trial process, and approves the trial protocol.
- The institution or organization at which the trial will be conducted, and the final approval for the conduct of the trial takes place at the site. Therefore, often called an ‘Approving Authority.’
- The sponsor is solely responsible for all approvals before supplying the ‘unapproved’ therapeutic good in the clinical trial.
The CTA Scheme is an approval process involving the following:
- The sponsor has to apply to TGA through an application with relevant fees, seeking the approval to supply ‘unapproved’ therapeutics goods for clinical trials.
- TGA evaluates the summary information about the product before the start of the clinical trial.
- The HREC is responsible for considering the scientific and ethical issues of the proposed trial protocol.
- The sponsor must notify TGA of each trial conducted using the unapproved therapeutic good approved in the CTA application.
To know more about clinical trials and to get end-to-end Regulatory support in Australia, reach out to Freyr experts.