Pediatric Drugs ( IF 3.4 ) Pub Date : 2022-08-13 , DOI: 10.1007/s40272-022-00530-1 Ann-Katrine Birkelund Mogensen 1 , Helle Christiansen 1 , Marie Louise De Bruin 1, 2 , Christine Erikstrup Hallgreen 1
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Background
As part of the European Paediatric Regulation, the European Medicines Agency (former European Medicines Evaluation Agency) and the Paediatric Working Party (precursor for the Paediatric Committee) revised a priority list for studies on off-patent medicinal products in 2007 where a need for studies on paediatric medicinal products was emphasised.
Objectives
We aimed to evaluate the status of guidance for paediatric use in the Summary of Product Characteristics for medicinal products on the priority list as well as the presence and status of Paediatric Investigation Plans for these medicinal products.
Methods
We included active pharmaceutical ingredients on the priority list authorised through the centralised procedure and/or marketed in Denmark. The status of guidance for paediatric use (indication, posology and/or contraindication) was reviewed from the most recent Summary of Product Characteristics uploaded on the European Medicines Agency or the Danish Medicines Agency website as of November 2020. Information on Paediatric Investigation Plans status (Paediatric Committee opinion, completion and waivers granted) was retrieved from the European Medicines Agency website.
Results
A total of 121 active pharmaceutical ingredients were included in this study. Seventy-one percent had guidance for paediatric use in the Summary of Product Characteristics for at least one paediatric subpopulation, more often concerning adolescents (70%) and children (70%) as compared with neonates (41%) and infants (49%). The guidance included a paediatric indication in 46% of the cases, but less often a contraindication (13%). Thirty-three active pharmaceutical ingredients had an agreed Paediatric Investigation Plan, six of these were completed.
Conclusions
Most active pharmaceutical ingredients from the priority list had guidance for paediatric use in the Summary of Product Characteristics. However, there is still an unmet need in relation to guidance for use for the youngest paediatric subpopulation.
中文翻译：
旧医药产品的新信息：欧洲专利过期医药产品优先清单中物质的儿科使用指南的横截面分析
背景
作为欧洲儿科法规的一部分，欧洲药品管理局（前欧洲药品评估机构）和儿科工作组（儿科委员会的前身）于 2007 年修订了对非专利药品研究的优先清单，其中需要研究强调儿科药品。
目标
我们旨在评估优先列表中药品产品特性摘要中儿科使用指南的状态，以及这些药品的儿科调查计划的存在和状态。
方法
我们将活性药物成分列入通过集中程序授权和/或在丹麦销售的优先清单。从截至 2020 年 11 月在欧洲药品管理局或丹麦药品管理局网站上上传的最新产品特性摘要中审查了儿科使用指南的状态（适应症、剂量学和/或禁忌症）。关于儿科调查计划状态的信息（儿科委员会的意见、完成和豁免）检索自欧洲药品管理局网站。
结果
本研究共纳入 121 种活性药物成分。71% 的人在至少一个儿科亚群的产品特性总结中提供了儿科使用指南，与新生儿 (41%) 和婴儿 (49%) 相比，青少年 (70%) 和儿童 (70%) 更常见. 该指南在 46% 的病例中包括儿科适应症，但较少出现禁忌症 (13%)。33 种活性药物成分已达成一致的儿科调查计划，其中 6 种已完成。
结论
优先列表中的大多数活性药物成分在产品特性摘要中都有儿科使用指南。然而，对于最年轻的儿科亚群的使用指南，仍然存在未满足的需求。
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