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[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。
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[Abstract]
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.
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