EMEA-EFPIA Information Day 2009, which was held on 24 February 2009 in London, included several interesting presentations about eCTD and NeeS.
Claire Holmes of EMEA presented on eCTD/Non eCTD electronic Submission (Nees): impact on the centralised procedure. Ms. Holmes explained the background of the recent announcement about mandatory eCTD: based on legal advice from EMEA, instruction was given that although eSubmissions cannot be mandated for the Centralised Procedure due to lack of legislative basis, it is possible to mandate the format of the eSubmission if received. Thus, the recent milestone of requiring all eSubmissions to be eCTDs by 1 January 2010. After that date, non-eCTD format electronic submissions will be rejected. Paper-only submissions will continue to be accepted, but will lead to handling and review issues as EMEA processes are being engineered for eSubmissions.
The number of eCTDs received has been increasing exponentially at EMEA (988 eCTD sequences since 1 July 2008). Around one-third of eSubmissions in recent months have been eCTDs. Although the majority of eCTDs are still new applications, an increasing number of converted “baselines” has been seen in the last six months.
There’s lots more in the presentation, especially concerning NeeS, but I’ll wrap up for today by repeating Ms. Holme’s Key Messages for Industry:
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