EMA Adopts Biologics Pharmacovigilance Practices

The European Medicines Agency (EMA) announced on August 15, 2016 that it was adopting a new chapter on biologics in its guidelines on good pharmacovigilance practices (GVPs), which come into effect on August 16, 2016.  The new chapter addresses the monitoring and management of the safety of biologicals and biosimilars in Europe.

Because of the complexity of biological drug products, EMA hopes the chapter will help in monitoring these products by highlighting the challenges involved in the pharmacovigilance of biologicals. The chapter provides recommendations for addressing these challenges and outlines the responsibilities of those involved in monitoring the safety of these products.

Specifically, the guideline covers risk management systems, risk analysis, periodic safety update reports, signal management, and safety communication. It also addresses market authorization and reporting of adverse reactions, and the roles and responsibilities of the different players involved are defined.