Clinical Trial Notifications

The Clinical Trial Notifications (CTN) scheme is a notification process where the Australian clinical trial sponsor notifies the Therapeutic Goods Administration (TGA) that their research involves an ‘unapproved’ good. Medicines and devices that do not appear on the Australian Register of Therapeutic Goods (ARTG) or are being used outside of the marketing approval are considered ‘unapproved’. Access and use of unapproved medicines and devices, including the use of placebo, requires notification to the TGA. The sponsor of the study is responsible for the notification process which is completed online. The notification process is complete and considered ‘acknowledged’ by the TGA once payment has been made. The sponsor must be in receipt of an ethics approval letter, site authorisation letter and TGA acknowledgement before supplying the ‘unapproved’ good.

For further information visit https://www.tga.gov.au/clinical-trials

Eye and Ear site specific requirements

Please use the details below in the CTN form: