首页 > 资讯 > EMA提醒采用新eCTD格式

出自识林

2012-12-07 EMA

EMA提醒递交eCTD将采用新格式，即从12月1号开始采用4.1版本。作为缓冲，EMA在2013年1月31日前仍然接受使用3.1版eCTD格式递交，但2013年2月1日起未采用4.1版本的eCTD递交文件将被拒收。

Applicants are advised that the new technical validation criteria v.4.1 for Electronic Common Technical Document (eCTD) came into force on 1 December 2012. The European Medicines Agency will continue to accept eCTD submission in the previous format v.3.1 until 31 January 2013. However, from 1 February 2013, any submission that does not comply with the new eCTD validation criteria v.4.1 will lead to non-acceptance of applications.

相关链接为：eSubmission