21 March 2009

SwissMedic eCTD Announcement

As previously covered by our friends at the eCTD Summit, recently the Swiss Regulatory Authority, SwissMedic, have announced their intentions and estimate timelines for eCTD adoption. Although the announcement and documentation is in German, we have provided the Google Translations for your browsing convenience:

The key part seems to be to ready yourself for draft guidance in July 2009, with the target of eCTD submissions to SwissMedic by Januray 2010. Similar to Austrailia, the expectation is that the Swiss eCTD will be similar to the EU eCTD is many ways.