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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS
FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH HARMONISED TRIPARTITE GUIDELINE
PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER)
E2C(R2)
Current Step 4 version
dated 17 December 2012
This Guideline has been developed by the appropriate ICH Expert Working Group and has been
subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the
Process the final draft is recommended for adoption to the regulatory bodies of the European Union,
Japan and USA.
