EMA提醒采用新eCTD格式
出自识林
EMA提醒采用新eCTD格式
笔记 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 |
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