Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years
Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years
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DOI：
10.1007/s00228-006-0193-0
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发表时间：
2006-11-01
影响因子：
2.9
通讯作者：
Wong, I.
中科院分区：
文献类型：
--
作者：
Ceci, A.;Felisi, M.;Wong, I.
目的1995-2005年的平衡EMEA的活动在儿科药物领域进行了评估，考虑到授权的儿童和儿科研究支持上市许可（MA）的药物数量（MA）.方法EMEA授权的药物数据提取EPAR（欧洲公共评估报告）。活性物质，批准年份，解剖，治疗和化学（ATC）代码，适应症，孤儿状态，年龄，和注册临床研究characteristics.Results儿科批准的物质的百分比为33.3%。当考虑不同的药物子集时，该百分比下降或增加[2岁以下儿童药物（23.4%），N-ATC代码药物（6%）和孤儿药（46.4%）]。在批准时，共有165项试验被纳入51种药物的MA档案中，另外22项研究被添加到提交用于儿科变化的12种活性物质的档案中。对32种（52%）活性物质进行了PK和疗效/安全性研究，而对43种（69%）和45种（73%）活性物质分别进行了一项PK或一项疗效/安全性研究。本报告表明，EMEA批准的儿科药物总数在10年期间保持稳定，而治疗严重或孤儿疾病的药物有所增加。此外，根据集中程序，已提交了大量宝贵的儿科试验，以支持药物审批。
Objective The 1995-2005 balance of EMEA activities in the field of paediatric medicines was evaluated, taking into account the number both of drugs authorised for children and paediatric studies supporting the Marketing Authorisation (MA).Methods Data on drugs authorised by EMEA were extracted from EPARs (European Public Assessment Reports). Active substance, year of approval, anatomical, therapeutic and chemical (ATC) code, indication, orphan status, ages, and registrative clinical studies characteristics were assessed.Results The percentage of authorised substances for paediatrics is 33.3%. This percentage decreased or increased when different subsets of medicines were considered [medicines for children under 2 years (23.4%), N-ATC code drugs (6%) and orphan drugs (46.4%)]. A total of 165 trials were included in the MA dossiers of 51 drugs at the time of approval, and additional 22 studies were added to the dossiers of 12 active substances submitted for paediatric variations. PK and Efficacy/Safety studies were performed for 32 (52%) active substances, while either one PK or one Efficacy/Safety study was carried out for 43 (69%) and 45 (73%) substances, respectively. Conclusions This report demonstrates that the total number of paediatric medicines approved by EMEA is stable over the 10-year period, while an increase in drugs to treat serious or orphan diseases has been observed. In addition, under the Centralised Procedure, a valuable number of paediatric trials have been submitted to support drug approval.