Update on Therapeutic Goods Administration and Biologics and Genetic Therapies Directorate (BGTD) of Health Canada - Parallel Review Project

March 2008

A candidate submission for the Canada-Australia Parallel Review Project has been selected by BGTD and TGA. Both regulatory authorities will carry out the review process independently, according to target review timeframes. The respective review processes will be conducted in parallel, in a spirit of collaboration and information sharing between the two organizations.

While this parallel process is intended to optimize learning and confidence-building across the two agencies, BGTD and TGA remain obligated to render their own individual review decisions and ensure that they meet their respective performance targets. It is understood that, as a consequence, outcomes may differ between the two jurisdictions. An evaluation of this pilot will inform continuous improvement of the review processes in both jurisdictions and may serve as a foundation for other parallel review pilots and possible joint review pilots in the future.