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CDE Consults on Technical Requirements for the Acceptance of Overseas Clinical Trial Data

 John Li  2017-11-14    2017-11-28

The Center for Drug Evaluation (CDE) of CFDA has published technical requirements for the acceptance of overseas clinical trial data for drug registrations in China. This is one of CFDA's recent efforts to encourage new product innovation and expedite the registration process for certain drugs for which there is urgent demand from Chinese patients. Industry can submit their comments to CDE before 25 Nov 2017.

Currently, all clinical trial data must be generated in China. Overseas clinical trial data must meet the specified technical requirements before they are accepted for use for drug registration in China.

关于《接受境外临床试验数据的技术要求》征求意见通知

为落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字[2017]42 号)要求,进一步加大鼓励创新的力度,加快临床急需药品的上市,尽早满足患者医疗需求,我中心制订了《接受境外临 床试验数据的技术要求》,现向社会公开征求意见。请于2017年11月25日前通过电子邮件反馈至我中心。

联 系 人:张帆, 电子邮箱 Email:zhangfan@cde.org.cn

Reference

http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314075

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