When will eCTD submissions be accepted without simultaneous submission of paper CTDs?
In the United States, eCTD is the mandatory electronic format for new submissions, although it is still possible to file paper submissions. The FDA will only accept eCTD submissions from companies that have demonstrated adequate technical competence in eCTD compilation, as established by FDA testing of a sample eCTD submission.In Europe, since 1July 2008, the EMEA has accepted eCTD submissions without the need to submit paper, although this change had little impact, initially because almost all CHMP members still required paper submissions when they were acting as rapporteur or co-rapporteur. From 31 December 2008, CHMP members are supposed not to be able to request paper copies, although it remains to be seen whether everybody will act in the spirit of the EMEA’s letter of intent. Further information is available on the EMEA website.With regard to EU national agencies, a target date of end 2009 was adopted at the European Heads of Agencies meeting in Reykjavik, Iceland, held on 23rd –
