7 August 2015

The ICH M4E(R2) Guideline reaches Step 2b of the ICH Process in August 2015 and now enters the consultation period (Step 3). The Section 2.5.1 on Product Development Rationale and Section 2.5.6 on Benefits and Risks Conclusions of the M4E(R1) Guideline have been revised to include greater specificity on the format and structure of benefit-risk information with the goal of harmonising the presentation of this information in regulatory submissions to facilitate communication among regulators and industries. 

The draft M4E(R2) document is available for download on the CTD page. You are invited to provide comments on the draft M4E(R2) Guideline (only on Sections 2.5.1 and 2.5.6) by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EU, USA, Japan, Canada and Switzerland are encouraged to submit their comments to their respective Regulatory Authorities.