Guidelines for better monitoring of biological medicines from EMA

The European Medicines Agency 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 to optimize the safe and effective use of these products in Europe.

Biological medicines contain one or more active substances made by or derived from a biological source, such as blood or plasma. Some of them may be already present in the human body and examples include proteins like insulin and growth hormone. The active substances of biological medicines are larger and more complex than those of non-biological medicines. Only living organisms are able to reproduce such complexity. Their complexity as well as the way they are produced may result in a degree of variability in molecules of the same active substance, particularly in different batches of the medicine.