11 April 2014

In March 2014, the ICH E2C(R2) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report and with a change in focus from individual case reports to more aggregate data evaluation.

This supplementary Questions and Answers document intends to clarify key issues which were identified since the ICH E2C(R2) Guideline was published in the three ICH Regions.

The ICH E2C(R2) Q&As document is available for download from the E2C Section on the Efficacy Guideline page.