29 January 2015

In November 2014, the ICH E2B(R3) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers which intends to clarify specific issues identified since the ICH E2B(R3) Guideline was published in the ICH Regions.

The ICH E2B(R3) implementation requires conceptual changes to business processes and due to differences in regional legislation, clarification was necessary on several new aspects.

The ICH E2B(R3) Q&As document is now available for download from the E2B(R3) page on the ICH ESTRI website.

The E2B(R3) IWG will continue to work towards addressing questions received from stakeholders. To contribute to this document, users are invited to submit their questions to E2BR3@ich.org.