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The EU Paediatric Regulation: Still a Large Discrepancy Between Therapeutic Needs and Approved Paediatric Investigation Plans

机译:欧盟儿科法规:治疗需求与批准的儿科研究计划之间仍然存在巨大差异

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摘要

Prior to the implementation of the EU Paediatric Regulation, the European Medicines Agency (EMA) defined unmet paediatric needs for active substances already available on the market. Seven years after the Paediatric Regulation came into force, we investigated the extent to which previously identified needs have led to programmes for generating evidence necessary for the regulatory approval of medicines for managing childhood conditions.
机译:在实施《欧盟儿科学规》之前,欧洲药品管理局(EMA)定义了市场上已有的活性物质的未满足儿科需求。 《儿科法规》生效七年后,我们调查了先前确定的需求在多大程度上导致了产生计划的必要性,这些计划为管理儿童疾病的药物的法规批准提供了必要的证据。

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