10 August 2011

In June 2011, the ICH Steering Committee approved the E3 Q&As Concept Paper to develop Questions and Answers to facilitate the application of the ICH E3 Guideline: Structure and Content of Clinical Study Reports and endorsed the establishment of an E3 Implementation Working Group (IWG). The group shall address the main issues identified since the implementation of the E3 Guideline in 1996, such as the alignment of E3 with the requirements of the Common Technical Document (CTD), particularly the requirements for electronic submission of this document (the “eCTD”).

For more details, see the E3 Q&As Concept Paper on the Efficacy Guideline page