In Australia, The Therapeutic Goods Administration (TGA) is responsible for the regulation of therapeutic goods (TG) – including medicines, vaccines, medical devices, in-vitro diagnostics and biologicals. They provide oversight over manufacturing, import and export of therapeutic goods, clinical trials (CT) and regulatory approvals processes.
Australia is well known for its efficient CT start up timelines; this is due to the TGAs Clinical Trial Notification (CTN) system. As of July 2015, the TGA released a new online CTN submission process – one of many developments intended to improve on the traditional paper CTN, which was considered administratively burdensome by the sponsor and the TGA alike.
The traditional process required a paper form to be completed accurately with the CT information and signed off by each party, including sites, before submission to the TGA. For a trial with only a few sites, the process was manageable; however, it became a challenge for the sponsor as the site numbers increased. Furthermore, any changes to the CT information required yet another version of the form to be completed and submitted – compounding the issues. Moreover, the TGA had to commit significant resources to the receipt, tracking and ongoing maintenance of these documents.
The roll out of the electronic CTN form or ‘eCTN’, will reduce the amount of resource and time commitment to managing this process. Sponsors are able to complete, submit and pay fees within the same web portal as well as receive instant feedback on when the CTN is received by the TGA. Multiple sites can be listed under one notification, instead of multiple versions of forms. Updates and edits to information can be made directly to the data already submitted. Overall the eCTN will simplify and improve the efficiency of the notification process for sponsors and the TGA. The TGA will be able to produce accurate metrics around CT activities and trends in Australia, benefiting sponsors and those looking to conduct research in Australia.
On a global scale, the TGAs CTN system has allowed Australia to possess some of the fastest study start up times. The implementation of the eCTN can only improve this reputation whilst reducing the time and resources spent on the administrative aspects of the CT notification, and ultimately speed up and simplify the process for the sponsor and the TGA. A transitional form is currently available to alert the TGA of any changes, made to a CT that utilised the traditional CTN form such as addition of sites. All notifications made to the TGA for new CTs after 1 July 2015 must be undertaken via the eCTN. The transitional process will continue to be available for trials notified prior to 1 July 2015.