Updated screening criteria for generic drug submissions

The Therapeutic Products Directorate (TPD) announces updated screening criteria for generic pharmaceutical pre-market submissions to replace the Integrated Review Process (pre-evaluation). TPD has made significant changes within the organisation to increase generic review performance capacity so that our review resources are focused in a manner which will enable us to reduce and eliminate the current backlog of generic drug submissions while at the same time minimise financial penalties. By eliminating the Integrated Review Process (IRP) for generic drugs and replacing it with the screening process, this will ensure that review resources are focused on the review of complete submissions. Read more here.