Lexchin Joel
School of Health Policy and Management, York University, Toronto, Canada; Department of Family and Community Medicine, University of Toronto, Toronto, Canada.
Health Policy. 2025 May;155:105314. doi: 10.1016/j.healthpol.2025.105314. Epub 2025 Apr 2.
To ensure that promising drugs for serious illnesses reach Canadians in a timely manner, Health Canada can approve them conditionally provided companies commit to conducting confirmatory studies to verify the benefits.
To determine how long it takes until the conditions are fulfilled and if certain factors affect that length of time.
A list of conditional approvals for new drugs and new indications for existing drugs to the end of 2024 was compiled from Health Canada databases. Orphan drug status was determined from the US Food and Drug Administration databases. Kaplan-Meier survival curves were constructed to determine how long it took to complete the studies.
There were 153 conditional approvals: 91 were fulfilled, 45 have not been fulfilled as of January 18, 2025 and 17 were withdrawn. The median time for fulfillment was 1200 (IQR 777, 1852) days. Orphan drug status and whether the conditional approval was for a new drug or a new indication for an existing drug did not affect the time to completion.
Some NOC/c take considerable time to be fulfilled. Health Canada should require studies to be underway at the time that a NOC/c is granted except in exceptional circumstances and it should be transparent about the completion date for confirmatory studies and provided detailed reports about any delays. In the case of delays that cannot be justified it should be given the power to impose significant financial penalties on manufacturers through the NOC/c pathway being converted from a policy into legislation.
为确保治疗严重疾病的有前景药物能及时惠及加拿大人，加拿大卫生部可进行有条件批准，条件是公司承诺开展确证性研究以核实药物益处。
确定满足这些条件需要多长时间，以及某些因素是否会影响所需时长。
从加拿大卫生部数据库中整理出截至2024年底的新药及现有药物新适应症的有条件批准清单。通过美国食品药品监督管理局数据库确定孤儿药状态。构建Kaplan-Meier生存曲线以确定完成研究所需时间。
共有153项有条件批准：91项已满足条件，截至2025年1月18日，45项未满足条件，17项被撤回。满足条件的中位时间为1200（四分位间距777，1852）天。孤儿药状态以及有条件批准是针对新药还是现有药物的新适应症，均不影响完成时间。
一些有条件批准需要相当长的时间才能满足。加拿大卫生部应要求在授予有条件批准时即开展研究，特殊情况除外，并且应公布确证性研究的完成日期，并提供有关任何延迟的详细报告。对于无法合理解释的延迟情况，应赋予其通过将有条件批准途径从政策转变为立法，对制造商处以重大经济处罚的权力。
