Marketing authorisation application dossiers relating to medicinal products containing new active substances and evaluated by the European Medicines Agency (EMA) over the period 2012–2015 were examined. Major objections and other concerns relating to efficacy and safety of the day 80 assessment reports were reviewed. Overall, approved products have more subgroup concerns than nonapproved products, which seems to be a consistent pattern. Subgroup analyses are mainly assessed to have the insurance that subgroups of patients that might lack a positive benefit: risk ratio will not be wrongly included in the approved treatment indication.

中文翻译：

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欧洲法规在营销授权申请中的使用和小组评估的影响

审查了与含有新活性物质的药品相关的销售许可申请文件，并由欧洲药品管理局（EMA）在2012-2015年期间对其进行了评估。审查了与80天评估报告有关的有效性和安全性的主要异议和其他问题。总体而言，批准的产品比未批准的产品具有更多的子类别问题，这似乎是一个一致的模式。主要评估亚组分析，以确保可能缺乏积极益处的亚组患者：风险比不会错误地包含在批准的治疗适应症中。