The eCTD summit

EMEA has released new versions of their electronic Application Forms (eAF) as part of Volume 2B - Presentation and content of the dossier.  All three forms (for new applications, variations and renewals) have been posted.  Updates are due to changes in the Data Exchange Standard Definitions released July 2009.  Changes are significant, so if you have done any custom development around the eAF, you will need to make a number of updates.  For those waiting for the EMEA to provide a front end for creating the form, you will only have to provide some additional information when filling in the form.

SwissMedic M1 specification v0.93 is available by contacting Stephan Jaermann (Stephan.Jaermann@swissmedic.ch).   However, before you do so, you should be aware that this does not consist of documentation updates yet, but only updates to the DTDs, style sheets and sample submissions.  If you are not highly interested in the technical aspects, you should hold off until more formal updates are posted.  Version 0.95 will be posted on the website towards the end of September. The final v1.0 version will be posted mid to end of October.