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EMA Explains How To Make Risk Minimization Measures Robust & Effective

 
• By Vibha Sharma

Pharmacovigilance experts speaking at an event organized by the European Medicines Agency discussed the rationale behind revised requirements relating to how drug sponsors must develop and evaluate risk minimization measures and thereby improve the safety of their medicines.

Hands of general practitioner filling paper medical records. Doctor in white coat doing paperwork at workplace with laptop, writing notes, preparing documents, reports, prescription. Close up
Patient and doctor representatives can contribute to user-testing of risk minimization materials • Source: Shutterstock

The European Medicines Agency’s updated guideline on risk minimization and the measures drug sponsors should take to ensure their products are used safely places greater emphasis throughout on the need to involve health care professionals and patient representatives in designing, testing, disseminating and evaluating the effectiveness of such measures.

Key Takeaways

  • The European Medicines Agency held a webinar to discuss its revised guideline on risk minimization measures (RMMs) and the related addendum on evaluating RMMs.

  • At the event, the EMA clarified the revised structure of the RMM guide, explained new terminologies and explained the reason for some of the changes.

  • The agency explained why there is greater emphasis throughout on involving health care professionals (HCPs) and patient representatives in designing, testing, disseminating and evaluating RMMs

While most risks for drug products can be sufficiently managed by routine risk minimization measures (eg, summary of product characteristics, package leaflet), others may require the use of additional RMM tools (eg,

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