Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
PAREXEL Consulting, PAREXEL International, Billerica, Massachusetts, USA.
Clin Pharmacol Ther. 2020 Jan;107(1):195-202. doi: 10.1002/cpt.1565. Epub 2019 Aug 14.
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have robust scientific and technical collaborations. As a window to the impact of these activities we compared the agencies' decisions on drug marketing applications. Decisions were compared for 107 new drug applications with a regulatory outcome at both agencies in the period 2014-2016. Further analysis addressed individual applications for which the agencies had differing outcomes in terms of marketing approval, type of approval, and approved indication, including reasons underlying differences. The EMA and the FDA had high concordance (91-98%) in decisions on marketing approvals. Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies' conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application. This high rate of concordance suggests that engagement and collaboration on regulatory science has a positive impact.
美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）之间建立了强大的科学和技术合作关系。作为评估这些活动影响的一个窗口，我们比较了这两个机构对药物营销申请的决策。比较了在 2014-2016 年期间，这两个机构都对具有监管结果的 107 种新药申请进行了决策。进一步的分析针对在营销批准、批准类型和批准适应症方面，机构之间存在不同结果的个别应用程序，包括差异背后的原因。EMA 和 FDA 在营销批准决策上具有高度一致性（91-98%）。批准决定、批准类型和批准适应症的差异主要是由于机构根据相同数据或支持申请提交的不同临床数据评估对疗效的结论不同。这种高度的一致性表明，监管科学方面的参与和合作具有积极影响。
