Swissmedic to Accept eCTD Submissions January 2010
The Swiss Health Authority Swissmedic intends to accept starting applications for admission in the eCTD format, i.e. in electronic form without paper documentation, starting in January 2010. The announcement is available (in German) on their website.
In support of this goal, Swissmedic initiated project SIMES (Solution for the implementation and the management OF electronics tender in December 2008.
The agency intends to largely follow European Union specifications with exception of module 1.
The project milestones include:
January 2009: Project Kickoff
Starting from March 2009: Publication of project information on the Swissmedic homepage (project status, Q& A-paper, announcements, etc.)
July 2009: The first version of the eCTD specification and the Praxisguidelines Swissmedic are available for the notification and examination. Submission types suited for the eCTD format are defined.
October 2009: The final version of the eCTD specification and the Praxisguidelines Swissmedic are available.
January 2010: Applications for admission in the eCTD format are accepted for defined submission types.