Changes to Health Canada Generics Screening Process

The Therapeutic Products Directorate of Health Canada has published an updated screening criteria for processing ANDS and SANDS pre-market submissions to replace the Integrated Review Process along with an attestation checklist required for submissions made after February 1, 2013.

According to the summary from Health Canada:

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.