The European Medicines Agency is inviting comments on the recently published ICH E2C (R2) guideline on periodic benefit-risk evaluation report (PBRER) from its stakeholders. The guideline reached step 2 of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) process in February 2012 and now enters step 3, the consultation period.

Stakeholders are asked to provide comments using this template. The comments template should be sent to  The deadline for comments is 21 May 2012.

Posted on EMA website on 16 April 2012