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CDE Consults on the Structure of Electronic Common Technical Document (eCTD) for Drug Registration

 John Li  2017-11-14    2017-11-24

The Center for Drug Evaluation (CDE) affilated with CFDA is inviting public comments on the structure of electronic common technical documents (eCTD) for drug registration. CFDA is currently in the process of standardizing the electronic submission content of drug registration dossier. Industry can submit their comments to CDE before 18 Nov 2017.

This marks a big step for China to move towards accepting eCTD submissions. The eCTD format consists of 5 modules and is developed based on ICH guidelines. Each module includes dozens of endpoints. The 5 modules are: administrative info, summary and overview, pharmaceutical research data (CMC), non-clinical research data (pharmacology and toxicology), and clinical data.

关于再次征求《药品电子通用技术文档结构》和《化学仿制药电子通用技术文档申报指导原则》意见的通知

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)中关于完善电子通用技术文档系统,逐步实现各类注册申请的电子提交和审评审批的工作要求,我中心对前期《药品电子通用技术文档结构(征求意见稿)》和《化学仿制药电子通用技术文档申报指导原则(征求意见稿)》进行了修改完善,现再次对社会公开征求意见。社会各界对修改后的稿件如有意见,请于2017年11月18日前通过电子邮件反馈至我中心。

联 系 人:李海玲 , 电子邮箱Email:lihl@cde.org.cn

Reference

http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314045

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