歐洲藥品管理局（EMA）發(fā)布的“兒科藥品研發(fā)指導原則”，反映出EMA當前對兒科新藥研發(fā)研究內(nèi)容的要求，我國目前尚未有類似指導原則。介紹EMA該指導原則的主要內(nèi)容，以期對我國兒科藥品的研發(fā)和監(jiān)管提供借鑒。

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.