Rawson N S
Royal University Hospital, Saskatoon, Saskatchewan, Canada.
Int J Health Serv. 1995;25(1):153-65; discussion 167-71. doi: 10.2190/3XHM-EW8F-5HJY-2D5N.
In a recent article, Lexchin asks "who needs faster drug approval times in Canada?" and, on the basis of extremely limited and selective data, draws the conclusion that neither the public nor the pharmaceutical industry does. Whether the Canadian system is really slower is investigated by comparing Canadian and U.S. marketing approval dates and by using information on regulatory approval times from the two countries and elsewhere. Marketing approval dates in Canada are significantly later than those in the United States, although not consistently across all therapeutic categories; anti-cancer and gastrointestinal drugs have earlier approval dates in Canada. However, Canadian and U.S. regulatory approval times are not significantly different, indicating that marketing applications are submitted later in Canada, but both are considerably longer than those in the United Kingdom. The evidence shows that Canadians need faster drug approval times if individuals requiring the medications are not to suffer unnecessarily. A significant decrease in drug approval times and the establishment of comprehensive and effective postmarketing surveillance would reduce the time it takes for new drugs to be made available to Canadians while, at the same time, providing a high level of drug safety.
在最近的一篇文章中，莱克辛问道“加拿大谁需要更快的药物审批时间？”，并基于极其有限且有选择性的数据得出结论：公众和制药行业都不需要。通过比较加拿大和美国的上市批准日期，并利用来自两国及其他地方的监管批准时间信息，对加拿大系统是否真的更慢进行了调查。加拿大的上市批准日期明显晚于美国，不过并非在所有治疗类别中都是如此；抗癌药和胃肠药在加拿大的批准日期更早。然而，加拿大和美国的监管批准时间没有显著差异，这表明在加拿大上市申请提交得更晚，但两者都比英国的批准时间长得多。有证据表明，如果需要药物治疗的个人不想遭受不必要的痛苦，加拿大人需要更快的药物审批时间。大幅缩短药物审批时间并建立全面有效的上市后监测，将减少新药供应给加拿大人所需的时间，同时提供高水平的药物安全性。
