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Regulatory Focus

机译:监管重点

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摘要

In this issue of The Regulatory Affairs Journal - Pharma we publish two articles and two editorials about the financing of pharmaceutical regulation through the mechanism of industry user fees. For more than a decade, user fees have helped finance the cost of drug regulation in the US, and recently this practice has expanded to the medical device and veterinary sectors. Our guest authors examine the history of user fees, the relationship between fees and review times, and the issue of whether or not user fees represent a conflict of interest for the regulatory authorities. We do not examine the question of whether user fees have affected the quality of decisions by these authorities.
机译:在本期《法规事务杂志-医药》中,我们发表了两篇文章和两篇社论,涉及通过行业用户收费机制为药品监管筹集资金。十多年来,使用费在美国帮助筹集了药品监管费用,最近这种做法已扩展到医疗设备和兽医领域。我们的来宾作者检查了用户费用的历史记录,费用与审查时间之间的关系以及用户费用是否代表监管机构的利益冲突的问题。我们不审查用户费用是否影响这些主管部门的决策质量的问题。

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