23 October 2012

In October 2012, the Draft eCTD Implementation Guide (v0.1) was released under Step 2 for Testing to give an opportunity to stakeholders to conduct testing to confirm its technical feasibility.

The ICH eCTD Draft Implementation Guide v1.0 and the Draft ICH Code List are made available for public awareness until March 1, 2013.

Further information and the Step 2 for Testing document package can be found on the eCTD Step 2 for Testing page of the ESTRI site.