14 July 2016

The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).  

The M4E(R2) Guideline includes greater specificity on the format and structure of benefit-risk information, harmonising the presentation of this information in regulatory submissions.

The M4E(R2) is available for download under the Multidisciplinary/CTD Guideline page on the ICH website.