The ICH M8 Expert Working Group (EWG) has published the eCTD v4.0 Step 4 Implementation Guide and related files. Some regulators planning pilot projects for 2017. “eCTD4 IG”:http://goo.gl/UGS0ef
April 01, 2016
For $99/year, access everything IRISS has to offer.
Subscriptions are free for government agency employees.