Delay in the Submission of the Results of Confirmatory Studies to Health Canada: A Cross-Sectional Study.

Abstract

Health Canada, Canada's national regulatory agency, conditionally approves new drugs and new indications for existing drugs (grants them a Notice of Compliance with conditions, NOC/c) and then requires confirmatory studies to validate efficacy and safety. Delays can occur between the expected time of submission of confirmatory studies and the actual time. Health Canada does not report on the status of ongoing confirmatory studies. This study looks at whether delays exist, how often they occur, and how long they are. The additional therapeutic value of drugs was assessed to determine if delays might have had therapeutic implications. Cross-sectional. Participants Drugs receiving a conditional approval between September 1, 2012, and May 31, 2025, and had information about when submissions of the results of confirmatory studies were expected and when they were actually submitted. Interventions None. Main Measures Percent of drugs that had information about when submissions were expected. Delay between expected and actual submission of results. Additional therapeutic value of drugs. Whether orphan drug status, number of confirmatory studies, and anatomic/therapeutic/chemical status predicted the length of delay. Key Results Twenty-four (25%) of 96 drugs approved had information about when submissions were expected. Six drugs were excluded for a variety of reasons. Thirteen drugs had delays with a median of 636 days (IQR 184, 1049) (1.74 years). Three drugs had major new therapeutic value; 9 and 8 drugs had moderate and minor additional value, respectively. The multiple linear regression model was not significant, F(3,14) = 2.606, p = 0.0930. Health Canada should publicly report on the criteria it uses to set dates of expected submission of confirmatory studies and consistently and publicly report those dates. It should annually make public the progress of studies and the reasons why they are delayed.