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EMA To Beef Up Guidance On Additional Risk Minimization Tools

 
• By Vibha Sharma

Based on its experience of reviewing tools used by companies for additional risk minimization, the European Medicines Agency is planning to update its guidance on this topic with more information on how these tools can be better employed.

SideEffects
Additional Risk Minimization Is Needed When Routine Measures Are Insufficient • Source: Shutterstock

The European Medicines Agency has agreed on major changes to its guidance that explains how companies should select additional risk minimization tools to address specific safety issues with their medicines and study the effectiveness of these tools.

The updated guideline, which will include “pages and pages” of new information on various tools for additional risk minimization, is expected to be issued for stakeholder consultation around Christmas or early next year, the EMA’s Núria Semis-Costa said at the Drug Information Association’s

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