ArticleBritish journal of clinical pharmacology2015
Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy.
Article in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed.
- Era of surrogate endpoints and accelerated approvals: a comprehensive review on applicability, uncertainties, and challenges from regulatory, payer, and patient perspectives.European journal of clinical pharmacology · 2025Review
- The UK's Early Access to Medicines Scheme 10 years on: an evaluation using publicly available data.JRSM open · 2025Article
- COVID-19 Vaccine's Speed to Market and Vaccine Hesitancy: A Cross-Sectional Survey Study.Healthcare policy = Politiques de sante · 2023Article
- Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018.Orphanet journal of rare diseases · 2022Article
- Information about confirmatory studies required for new drugs conditionally approved by Health Canada: A cross-sectional study.PloS one · 2022Review
- Can adaptive clinical trials help to solve the productivity crisis of the pharmaceutical industry? - a scenario analysis.Health economics review · 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
- Caregivers' Willingness to Accept Expedited Vaccine Research During the COVID-19 Pandemic: A Cross-sectional Survey.Clinical therapeutics · 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
- Formulating an Ethics of Pharmaceutical Disinvestment.Journal of bioethical inquiry · 2020Article
- Health Canada's use of expedited review pathways and therapeutic innovation, 1995-2016: cross-sectional analysis.BMJ open · 2018Article
- Pharmacovigilance and expedited drug approvals.Australian prescriber · 2018Review
- Patients not patents: Drug research and development as a public enterprise.European journal of clinical investigation · 2018Article
- The Pharmaceutical Industry and the Canadian Government: Folie à Deux.Healthcare policy = Politiques de sante · 2017Article
- How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study.Healthcare policy = Politiques de sante · 2016Article
- The hazards of rapid approval of new drugs.Australian prescriber · 2016Article
- On the predictive utility of animal models of osteoarthritis.Arthritis research & therapy · 2015Review
- Article
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsHealth Canada has developed a pathway to approve drugs that have limited efficacy and safety data, the Notice of Compliance with conditions (NOC/c) policy. Increased safety reporting is required for these drugs but there has not been any systematic review of their post-market safety. This study compares safety warnings for NOC/c drugs with drugs with a priority and a standard review.
methodsA list of drugs approved between January 1 1998 and March 31 2013 was developed and serious safety warnings for these drugs were identified. Drugs were put into one of three groups based on the way that they were approved. Kaplan-Meier curves were generated to examine the likelihood of NOC/c drugs receiving a serious safety warning compared with drugs with a priority and a standard review. The time spent in the review process for each of the groups was also measured.
resultsCompared with drugs with a priority review, NOC/c drugs were not more likely to receive a serious safety warning (P = 0.5940) but were more likely than drugs with a standard review (P = 0.0113). NOC/c drugs spent less time in the review process compared with drugs with a standard review.
conclusionsPossible reasons for the increase likelihood of a serious safety warning are the limited knowledge of the safety of NOC/c drugs when they are approved and the length of time that they spend in the review process. Health Canada should consider spending longer reviewing these drugs and monitor their post-market safety more closely.
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