On July 1st, 2015 a new online form for Australia’s clinical trial notification (CTN Australia) scheme was made available. According to the TGA site, these notifications apply to the clinical trial or use of a product in Australia which is:
- not on the Australian Register of Therapeutic Goods
- on the ARTG but being used outside the conditions of its marketing approval
Over 95% of trials are approved through the CTN Australia. The TGA site states that this online form is a first step of many developments towards a better administrative process of these clinical trial schemes.
In wake of this new online form, the original paper version, which makes for a longer administrative process, will no longer be accepted.
The TGA notes many benefits of the new online form such as the ability to manage and track notifications through a personal online dashboard and make amendments to any clinical information directly and more efficiently.
Any paper versions of this form which have been submitted past July 1st will also need to be submitted online. The TGA is willing to work with affected clinical trial sponsors through this initial transition period.
Guidance material for the new CTN form is available on the TGA website.
Want to know more about our solutions? Speak to a RegDesk Expert today!