A6 – Introduction to changes to the TGA’s Clinical Trial Notification (CTN) process

The Therapeutic Goods Administration (TGA) will soon be transitioning from a paper based Clinical Trial Notification (CTN) process to an online process through the TGA’s online portal: eBusiness Services (eBS). The presentation will unveil the layout of the forthcoming online CTN form, highlight the changes from the paper CTN form and detail the reasons behind these changes and what they entail for a clinical trial sponsor. The session will explain the preparation required to be ready to utilise the online CTN form once it comes into effect and show how fees are to be charged and processed.

 

Please note: This presentation is a repeat of the recent roadshow sessions conducted by TGA on the CTN scheme’s process.