Observational studyBMJ open2021
Time to market for drugs approved in Canada between 2014 and 2018: an observational study.
Observational study in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Measuring the Outcomes of International Oncology Regulatory Collaboration in Canada from 2019 to 2025: Project Orbis.Clinical pharmacology and therapeutics · 2026Article
- CANLead: Canada as a Phase 1 Clinical Trial Leader - Opportunities, Initiatives, and Collaborative Innovation to Elevate National Competitiveness.The oncologist · 2026Article
- The Saudi FDA drug evaluation timeline in comparison with international counterparts: a retrospective observational study.Journal of pharmaceutical policy and practice · 2026Article
- Therapeutic coordination polymers: tailoring drug release through metal-ligand interactions.Chemical science · 2024Article
- Ethical considerations in international clinical trial site selection.BMJ global health · 2022Review
- The timelines for the price and reimbursement authorization in Italy 2018-2020.Frontiers in medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis study examines the length of time between when a patent application is filed in Canada for a new drug and when it is available for patients (time to market) and various components of that time. It also looks at whether various factors explain the time between patent application to New Drug Submission (NDS) and compares Canadian and American times. Drugs approved between 1 January 2014 and 31 December 2018 are examined.
designDescriptive study. DATA SOURCES: Websites from Health Canada, Food and Drug Administration, Merck Index, United States Patent and Trademark Office, WHO and previously published articles.
interventionsNone. PRIMARY AND SECONDARY OUTCOMES: The primary outcomes are time to market, time from patent application to NDS (pre-NDS time), review time, time from approval to availability (postapproval time) and factors that may influence the pre-NDS time. The secondary outcome is a comparison of Canadian and American review times and times between patent application and approval.
resultsThere were 113 drugs available for analysis. The median time to market was 11.80 years (IQR 9.40-14.05). The component median times were pre-NDS 10 years (IQR 8.05-12.80), review time 0.96 years (IQR 0.75-1.15) and postapproval time 0.15 years (IQR 0.08-0.28). Less than 8% of the pre-NDS time was explained by the factors that were analysed in a multiple linear regression equation. There was no statistically significant difference between Canadian and American pre-NDS times.
conclusionOnce a drug reaches the market, companies have a median of 8.2 years before the patent expires and generics can reach the market. Most of the time between the filing of a patent application and when a drug is marketed is determined by decisions that are largely under the control of the company.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.