国外儿科药物研发的监管要求和研发策略
发布时间：2018-08-18 13:17
【摘要】：从历史上看,药物用于儿童时通常没有获得像成人药物一样的安全性和有效性证据。随着人们对全球药品监管有关儿科药物研发互动协调的关注的不断增长,同时对儿童遗传性罕见病也给予了越来越多的支持和关注,尽早和监管机构接触的期望日渐增高。欧盟和美国的法律都强制性要求进行和支持儿科药物研发,同时包括随之而来的经济利益,即延长儿科用药的专利保护。在提交上市许可申请之前,欧盟儿科法规要求制药公司申请人与欧洲药品管理局(EMA)达成儿科研究计划的协议,而目前美国有4个儿科药物研发相关的法律,提出了儿科研究计划的要求。世界卫生组织推出了"量身定制儿童药物"的倡议。对于全球性药物开发项目,明智的做法是尽可能早地寻求欧盟EMA和美国FDA有关儿科药物研发计划的科学建议,并达成协议。
[Abstract]:Historically, drugs have been used in children without evidence of the same safety and efficacy as adult drugs. With the increasing attention to the interaction and coordination of paediatric drug research and development in global drug regulation, more and more support and attention has been paid to the rare genetic diseases in children, and the expectation of early contact with regulators is increasing. European Union and U.S. laws require and support paediatric drug development, including the attendant economic benefits of extending patent protection for paediatric drugs. Before filing for a listing license, EU paediatric regulations require pharmaceutical company applicants to enter into a paediatric research program agreement with the European Drug Administration (EMA), while there are currently four paediatric drug development laws in the United States. The requirements of the pediatric research program are put forward. The World Health Organization has launched a child-specific drug initiative. For a global drug development program, it would be wise to seek scientific advice from the European Union's EMA and the U.S. FDA on paediatric drug development plans as soon as possible and reach an agreement.
【作者单位】： 国家食品药品监督管理总局药品审评中心;Toxicology
【分类号】：R95
本文编号：2189583
[Abstract]:Historically, drugs have been used in children without evidence of the same safety and efficacy as adult drugs. With the increasing attention to the interaction and coordination of paediatric drug research and development in global drug regulation, more and more support and attention has been paid to the rare genetic diseases in children, and the expectation of early contact with regulators is increasing. European Union and U.S. laws require and support paediatric drug development, including the attendant economic benefits of extending patent protection for paediatric drugs. Before filing for a listing license, EU paediatric regulations require pharmaceutical company applicants to enter into a paediatric research program agreement with the European Drug Administration (EMA), while there are currently four paediatric drug development laws in the United States. The requirements of the pediatric research program are put forward. The World Health Organization has launched a child-specific drug initiative. For a global drug development program, it would be wise to seek scientific advice from the European Union's EMA and the U.S. FDA on paediatric drug development plans as soon as possible and reach an agreement.
【作者单位】： 国家食品药品监督管理总局药品审评中心;Toxicology
【分类号】：R95
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