EMA Invites Comments on ICH Risk-Benefit Guidance

Posted 16 April 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is inviting comments on newly-released guidance by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that seeks to harmonize standards between the US, EU and other countries.

ICH's standard, E2C(R2): Periodic Benefit-Risk Evaluation Report, was released by the organization 2 March 2012. The US Food and Drug Administration quickly followed suit, releasing their version of the standard 10 April for public comment.

EMA's 16 April guidance seeks comments on the E2C (R2) guideline, which "defines the recommended content and format of a periodic benefit-risk evaluation report (PBRER) and provides an outline of points to be considered in its preparation and submission."

The E2C (R2) standard seeks to ensure that marketed drugs contain all relevant safety and efficacy information.

Comments on the standard are due 21 May 2012.

Read more:

EMA - Comments invited on the ICH E2C (R2) guideline on periodic benefit-risk evaluation report

EMA - ICH guideline E2C (R2): Periodic benefit-risk evaluation report (PBRER)

Regulatory Focus - New ICH Guideline on Periodic Safety Update Reports

Regulatory Focus - ICH Safety Reporting Standard Advanced by FDA

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