SwissMedic announces plans for accepting eCTDs

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.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

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