;   Medical Translation Insight: swissmedic plans for eCTD submissions - ForeignExchange Translations

swissmedic plans for eCTD submissions

SwissMedic plans for eCTD submissionsStarting 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.


Did you like this post? Subscribe to Medical Translation Blog via email or RSS.

0 Comments:

Post a Comment





 

Services | Resources | Company | Contact Us | Blog | Home

(c) Copyright 2010, ForeignExchange Translations, Inc.