15 July, 2023

EMA Report on Pharmacovigilance Tasks (2019-2022)

The EMA’s 2019-2022 report on pharmacovigilance (PV) tasks, published in June 2023, highlights the European regulatory network’s effective response to the Covid-19 pandemic, emphasizing preparedness, established PV tools, and collaborative innovation. The report details EMA’s progress in leveraging real-world evidence (RWE) through the Big Data Steering Group to advance treatment outcomes and expedite patient access.

This article covers key activities in pharmacovigilance, including PRAC efforts, adverse reaction reporting, and the modernization of EudraVigilance (EV) for improved data analysis. It also outlines forward-looking steps to enhance automation, expand real-world data use, and strengthen clinical engagement through initiatives like PRISMA, setting the stage for even more responsive PV in future public health challenges.

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