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EMA Overhauls Guidance On Risk Minimization Activities

 
• By Vibha Sharma

Drug companies may have to adjust their benefit-risk management strategies to ensure compliance with the European Medicines Agency’s newly revised guidance on how to develop and evaluate risk minimization measures.

Medicine, help and pharmacist advice with side effects at health store counter for customer service. Pharmaceutical advice and opinion of worker helping girl with medication information at pharmacy.
Educational Materials, Package Leaflets And Restricted Pack Sizes Are All Types Of Risk Minimization Activities • Source: Shutterstock

The European Medicines Agency has published keenly-awaited revised EU guidance on what measures drug companies can employ to prevent or minimize the risks associated with their products, along with a revised addendum on how to gauge the effectiveness of such measures.

Key Takeaways

  • The European Medicines Agency has finalized long-awaited changes to its good pharmacovigilance guideline Module XVI on risk minimization measures (RMM) and a related addendum.

  • ...

The revisions were made to the guideline on risk minimization measures (RMMs) – ie, Module XVI of the EMA’s Good Pharmacovigilance Practices (GVP) guideline series – and the related...

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