Breitkreutz Jörg
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Düsseldorf Germany.
Clin Ther. 2008 Nov;30(11):2146-54. doi: 10.1016/j.clinthera.2008.11.016.
The 2007 European Union (EU) regulation on medicinal products for pediatric use may change the present unsatisfying situation in the EU by stimulating research and development of medicines for use in children through rewards and incentives.
This commentary reflects on the new EU regulations and guidelines, with special attention paid to the impact on pediatric formulation science. The focus of this article is on the EU perspective for pediatric formulations and highlights the differences compared with the pediatric drug formulation situation in the United States.
Materials for this article were gathered during a literature search of MEDLINE and Chemical Abstracts (1970-October 2008) using the following terms: paediatric/pediatric drug formulations, age-appropriate dosage forms, child-appropriate medicines, and paediatric/pediatric regulation.
Since the EU legislation on medicines for children came into force in 2007, a great emphasis has been placed on creating new organizations, scientific networks, and programs dealing with pediatric medicines and child-appropriate drug formulations. Although the US legislation was an appropriate model, the EU introduced some novel measures to improve the current situation, such as the Paediatric Investigation Plan and the Paediatric Use Marketing Authorisation. For globally operating pharmaceutical companies, the peculiarities of the European market have a strong impact on their product development strategies. Because the European approach demands early investigations into drug formulations for children, various issues must be resolved, including the following: choosing formulations for each age group, determining which excipients may be used in the formulation and which delivery device is appropriate, and predicting the taste sensation of an oral formulation. Numerous initiatives and networks are evolving in Europe. An important future task will be the coordination of these activities and the linking to other groups working on pediatric formulations outside the EU.
Similar to the research in pediatric drug formulations that was stimulated by the US legislation and incentives of the last decade, the 2007 EU legislation promises improvements in the availability of child-appropriate drugs in Europe.
2007年欧盟关于儿科用药品的法规可能会通过奖励和激励措施刺激儿童用药的研发，从而改变欧盟目前不尽人意的状况。
本评论对欧盟新法规和指南进行反思，特别关注其对儿科制剂科学的影响。本文重点在于欧盟对儿科制剂的观点，并突出与美国儿科药物制剂情况的差异。
本文材料通过检索MEDLINE和《化学文摘》（1970年 - 2008年10月）收集，使用以下检索词：儿科/儿童药物制剂、适合年龄的剂型、适合儿童的药品、儿科/儿童法规。
自2007年欧盟儿童用药立法生效以来，已大力强调创建处理儿科药品和适合儿童的药物制剂的新组织、科学网络及项目。尽管美国立法是合适的典范，但欧盟引入了一些新措施来改善当前状况，如儿科研究计划和儿科用途上市许可。对于全球运营的制药公司而言，欧洲市场的特殊性对其产品开发策略有重大影响。由于欧洲的方法要求对儿童药物制剂进行早期研究，因此必须解决各种问题，包括：为每个年龄组选择剂型、确定制剂中可使用哪些辅料以及哪种给药装置合适，以及预测口服制剂的味道。欧洲正在涌现众多倡议和网络。未来一项重要任务将是协调这些活动，并与欧盟以外从事儿科制剂工作的其他团体建立联系。
与过去十年美国立法和激励措施所推动的儿科药物制剂研究类似，2007年欧盟立法有望改善欧洲适合儿童药物的可及性。
