GVP: A New Chapter
A new chapter of Good Pharmacovigilance Practice (GVP), added by the European Medicines Agency (EMA) is coming into effect today. It is called “Product- or population-specific considerations II: Biological medicinal products” and contains guidelines for control and management of biological drug safety to optimize the safe and effective use of these products in EU, including biological drugs, biosimilars and products containing equivalent or similar active substances, but not authorized as medicinal drugs.
At the same time, the chapter does not relate to vaccines and products for genetic-cell-and tissue-engineered drugs. These drugs are regulated by another guidelines.