ArticleBMJ open2018
Health Canada's use of expedited review pathways and therapeutic innovation, 1995-2016: cross-sectional analysis.
Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed.
- Assessing the Opportunity for an Accelerated Access Pathway for Health Canada Priority Review Drugs: A Comparative Analysis with Ontario's FAST Pilot Program.Current oncology (Toronto, Ont.) · 2026Article
- Characteristics of clinical trials associated with appeal and return on investment to participants: a review and framework.The oncologist · 2025Review
- Are Therapeutically Important Drugs No Longer Available in Canada?Healthcare policy = Politiques de sante · 2025Article
- Putting the substance in substantial evidence: an evidence-based approach to flexible drug regulation.Frontiers in medicine · 2025Article
- A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia.Pharmaceutical medicine · 2023Article
- Treatment Access, Health Economics, and the Wave of a Magic Wand.Current oncology (Toronto, Ont.) · 2022Article
- Information about confirmatory studies required for new drugs conditionally approved by Health Canada: A cross-sectional study.PloS one · 2022Review
- Few new drugs deserve expedited regulatory treatment.Journal of managed care & specialty pharmacy · 2021Article
- Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness.Frontiers in medicine · 2021Article
- Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities.Clinical therapeutics · 2021Review
- It's Time to Finally Kill the Zombies Comment on "Universal Pharmacare in Canada".International journal of health policy and management · 2020Article
- Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.BMJ (Clinical research ed.) · 2020Article
- Health Canada's Proposal to Accelerate New Drug Reviews.Healthcare policy = Politiques de sante · 2020Article
- Commentary: Expedited Regulatory Review of Low-Value Drugs.Healthcare policy = Politiques de sante · 2020Article
- Leading Causes of Mortality and Prescription Drug Coverage in Canada and New Zealand.Frontiers in public health · 2020Article
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis study examines the use of expedited approval pathways by Health Canada over the period 1995 to 2016 inclusive and the relationship between the use of these pathways and the therapeutic gain offered by new products.
designCross-sectional study. DATA SOURCES: Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, Notice of Compliance database, Notice of Compliance with conditions web site, Patented Medicine Prices Review Board, La revue Prescrire, WHO Anatomical Therapeutic Chemical classification system. PRIMARY AND SECONDARY OUTCOMES: Percent of new drugs evaluated by Health Canada that went through an expedited pathway between 1995 and 2016 inclusive. Kappa values comparing the review status with assessments of therapeutic value for individual drugs.
resultsOf 623 drugs approved by Health Canada between 1995 and 2016, 438 (70.3%) drugs went through the standard pathway and 185 (29.7%) an expedited pathway. Therapeutic evaluations were available for 509 drugs. Health Canada used an expedited approval pathway for 159 of the 509 drugs, whereas only 55 were judged to be therapeutically innovative. Forty-two of the 55 therapeutically innovative drugs received an expedited review and 13 received a standard review. The Kappa value for the entire period for all 509 drugs was 0.276 (95% CI 0.194 to 0.359) indicating 'fair' agreement between Health Canada's use of expedited pathways and independent evaluations of therapeutic innovation.
conclusionHealth Canada's use of expedited approvals was stable over the entire time period. It was unable to reliably predict which drugs will offer major therapeutic gains. The findings in this study should provoke a discussion about whether Health Canada should continue to use these pathways and if so how their use can be improved.
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