Medsafe News
Introducing an Extended
Abbreviated Evaluation Process
(effective from 3 March 2008)
22 February 2008
From 3 March 2008, an extended business rule for abbreviating the new medicine evaluation process for eligible applications will be implemented. The extended rule builds on the abbreviated process available for high- and intermediate-risk medicines that have been assessed and approved by the Therapeutic Goods Administration of Australia. A reduced fee will apply to applications that are evaluated under the new business rule.
To be eligible for the extended abbreviated process the application must be for a medicine that:
- has been approved by one of a range of recognised regulatory authorities prior to submission of an application to Medsafe; and
- is marketed in that country at the time of submission of the application
For more information, see Updated Guideline Information.