Guideline on Good Pharmacovigilance Practices (GVP). Product- or Population-Specific Considerations II: Biological
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“. 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.
This Module applies to all biological medicinal products regardless of the regulatory pathway of approval or market exclusivity status, i.e. it applies to reference biological medicinal products, to ‘similar biological medicinal products’ and to products which contain the same or closely related active substance but not authorised as biosimilars (e.g. different versions of interferon beta-1a, factor VIII or normal human immunoglobulin).
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