Better monitoring of biological medicines

New chapter in guidelines on good pharmacovigilance practices

The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled “Product- or population-specific considerations II: Biological medicinal products”. Good pharmacovigilance practices are a set of measures designed to ensure the robustness of the system of safety monitoring. The new chapter provides guidance on how to better monitor and manage the safety of biological medicines to optimise the safe and effective use of these products in Europe.

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