介绍欧洲药品管理局治疗失眠药物临床试验指导原则及在特殊人群的研究要求

Introduction on the clinical guideline of investigation medicinal products for insomnia and study requirement in special people by European Medicine Agency

本文参考欧洲药品监督管理局人用药品委员会2011年2月最新发布的治疗失眠药物临床试验指导原则,简略介绍了治疗失眠药物临床试验的一般考虑以及在特殊人群中进行研究的相关要求。

The article refers to guideline on medicinal products for the treatment of insomnia published by EMA Committee for Medicinal Products for Human Use（CHMP） on Feb 2011.It introduces the common principle for the clinical investigation on medicinal products for the treatment of insomnia and the requirement in special people.