Use of international assessments

TGA may use international assessments to reduce the duplication of effort where an assessment has already been conducted outside Australia.

20 December 2017

TGA makes use of assessments from comparable overseas regulators (CORs) and international assessment bodies, where possible, in the regulation of medicines. This can reduce the duplication of effort where an assessment has already been conducted outside Australia. Depending on the scope of the assessment that can be provided to TGA, the need for a de novo evaluation may be reduced or removed.

We currently use medical device conformity assessment certification from European notified bodies and are looking to increase the use of international assessments and approvals from other comparable overseas regulators when deciding whether to include a medical device on the ARTG.

The criteria used to identify a comparable overseas regulator and the processes for using overseas assessments differ depending on the type of therapeutic good.