歐洲藥品管理局（EMA）發(fā)布的“兒科藥品研發(fā)指導(dǎo)原則”，反映出EMA當(dāng)前對(duì)兒科新藥研發(fā)研究?jī)?nèi)容的要求，我國(guó)目前尚未有類似指導(dǎo)原則。介紹EMA該指導(dǎo)原則的主要內(nèi)容，以期對(duì)我國(guó)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.