Regulatory Focus™ > News Articles > New ICH Guideline on Periodic Safety Update Reports

New ICH Guideline on Periodic Safety Update Reports

Posted 06 March 2012 | By Alexander Gaffney, RAC 

A new draft guideline put forth by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aims to "be a common standard for periodic benefit-risk evaluation reporting" for products marketed in ICH regions.

The draft guidance, entitled E2C(R2): Periodic Benefit-Risk Evaluation Report,  aims to "ensure that the periodic safety update reports for marketed drugs have the role of being periodic benefit-risk evaluation reports (PBRER) by covering: safety evaluation, evaluation of all relevant available information accessible to marketing authorization holders."

The guidance also "defines the recommended content and format of a PBRER and provides an outline of points to be considered in its preparation and submission."

Read more:

ICH - E2C(R2): Periodic Benefit-Risk Evaluation Report

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