swissmedic plans for eCTD submissions
Written by ForeignExchange Translations on Monday, May 04, 2009
Starting in January of 2010, Switzerland will accept eCTD submissions. In preparation for this, swissmedic has launched project SIMES ("Solution for the Implementation and the Management of Electronic Submissions").
swissmedic will largely follow the EU implementation of the ICH specification. The main differences will be in module 1.
While the first e-submissions are scheduled for January 2010, this won't be an all-encompassing switchover. Only certain types of applications will be supported and features like electronic signatures will be implemented in future enhancements.
Go to swissmedic's web site to access information on eSubmissions, project SIMES, and eCTD documentation/news.
As more and more jurisdictions embrace (and sometimes even require) eCTD submissions, translators face new challenges and need to get up-to-speed on the structure and peculiarities of these electronic submissions.
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