Snapshot

The Priority Review of Drug Submissions pathway has been developed by the HealthCanada of Canada.

It is an abridged review (a reliance pathway).

Priority Review status allows for the insertion of eligible drug submissions into Health Canada's submission workload on the basis of a shortened review target of 180 calendar days. As such, qualifying submissions may undergo review in advance of non-eligible submissions in accordance with approaching target dates. *Submission workload consists of all submission types, differentiated across biological, pharmaceutical and medical device product lines. Specific therapeutic expertise within the Biologics and Genetic Therapies Directorate (BGTD) and the Therapeutic Products Directorate (TPD) is directed towards the review of corresponding submission types where required. As such, the review of a priority submission will commence before the review of other pending submissions of the same therapeutic area, which have a target completion date after that of a priority submission. The review of submissions with a target review date preceding the target review date of the priority submission, will not be disrupted. Once priority review status has been granted, there is a stated expectation that the submission will: (1) be filed within 60 calendar days; (2) contain the information and material for the purposes of Division 8, Part C of the Food and Drug Regulations; and (3) be subject to the Guidances for Industry Management of Drug Submissions.