Measuring regulatory outcomes

How EMA wants to use real-world data to study the health impact of safety decisions

EMA wants to increase the use of real-world evidence and digital health to better understand the impact of pharmacovigilance decisions on patient outcomes.

Pharmacovigilance decisions fall along a broad continuum, from small changes such as reducing the size of a packet of pills or adding a drug-drug interaction to a drug label, to larger decisions such as restricting an indication or withdrawing a drug from the market.

An EMA review of over 1,200 publications on studies assessing the impact of pharmacovigilance decisions found that only 25% evaluated whether a pharmacovigilance decision improved outcomes. Instead, the majority analyzed whether the decision was implemented by recording changes in drug prescriptions following a pharmacovigilance action.

In addition, very few studies analyzed whether

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