Regulatory Focus™ > News Articles > ICH Safety Reporting Standard Advanced by FDA

ICH Safety Reporting Standard Advanced by FDA

Posted 10 April 2012 | By Alexander Gaffney, RAC 

A month after the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) released new standards on periodic benefit-risk evaluation reporting, the US Food and Drug Administration (FDA) has released a draft guidance document seeking to bring the US into conformity with the standard.

FDA's 10 April draft guidance document, E2C(R2) Periodic Benefit-Risk Evaluation Report, seeks to combine and implement two ICH guidances-E2CClinical Safety Data Management:  Periodic Safety Update Reports for Marketed Drugs and Addendum to E2C Clinical Safety Data Management:  Periodic Safety Update Reports for Marketed Drugs.

As Regulatory Focus reported in March 2012, that guidance 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."

"The draft guidance describes the format, content, and timing of a PBRER for an approved drug or biologic," wrote FDA in its draft guidance announcement. "The harmonized PBRER is intended to promote a consistent approach to periodic postmarket safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.

Read more:

FDA - Draft Guidances for Industry; Availability, etc.: International Conference on Harmonisation, E2C(R2) Periodic Benefit-Risk Evaluation Report

Regulatory Focus - New ICH Guideline on Periodic Safety Update Reports

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