摘要
欧洲药品管理局(EMA)发布的"儿科药品研发指导原则",反映出EMA当前对儿科新药研发研究内容的要求,我国目前尚未有类似指导原则。介绍EMA该指导原则的主要内容,以期对我国儿科药品的研发和监管提供借鉴。
European Medicines Agency＇s ＂Guideline onPharmaceutical Development of Medicines for Paediatric Use＂,has reflected its current requirement on pharmaceutical development of medicines for paediatric use,but there is no similar guidance in our country until now.The article introduces the main contents of this guideline in ordor to provide the reference for the development and administration of medicines for paediatric use in China.
出处
《药物评价研究》
CAS
2013年第6期401-409,共9页
Drug Evaluation Research
关键词
儿科药品
新药研发
欧洲药品管理局
药品管理
medicines for paediatric use
new drug research and development
European Medicines Agency
drug administration
