
EMA Adopts Biologics Pharmacovigilance Practices
The agency has adopted guidelines on the pharmacovigilance of biological drugs.
The European Medicines Agency (EMA)
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.
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