The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster paediatric research addressing unsolved and uncovered issues within a ‘translational approach’ has appeared. This article, after having clarified the concept of translational research in the perspective of the establishment of a European paediatric research infrastructure (RI), will identify and point out ethical, legal and regulatory issues particularly relevant in a children’s rights perspective. It concludes asking for the setting up of an adequate model of governance within a future RI, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children.

缺乏儿科药物，包括创新和先进的药物，在欧洲和国际层面是一个长期存在且众所周知的问题。尽管有现有的法律框架和激励措施，但由于在适当研究和为他们定制药物和其他产品方面面临挑战，儿童仍然无法获得多种治疗。在这种情况下，出现了促进儿科研究以“转化方法”解决未解决和未发现问题的必要性。本文在从建立欧洲儿科研究基础设施 (RI) 的角度阐明了转化研究的概念后，将确定并指出与儿童权利角度特别相关的伦理、法律和监管问题。