The European Medicines Agency ("EMA") has adopted a new chapter to its guidelines on good pharmacovigilance practices ("EU-GVP"), titled "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 with a view to optimizing the safe and effective use of these products in Europe. The guidance seeks to support those responsible for monitoring these medicines by:

  • Highlighting specific issues and challenges for the pharmacovigilance of biological medicines, e.g., in relation to variability of the active substance or traceability of products;
  •  Providing recommendations on how to address these specificities and challenges; and
  • Outlining the roles and responsibilities of the various actors.

The GVP guidance was effective on August 16, 2016.

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