PIDs in the EU: A regulator's perspective of intravenous immunoglobulins (IVIGs)

Abstract

This chapter on the EU regulatory perspective of the intravenous immunoglobulins (IVIGs) encompasses the following topics:

– Regulatory framework for IVIGs;

– Current EMEA initiatives: revision of the core SPC/IVIG Guideline;

– Paediatric Regulation: impacts/outcomes;

– Patient involvement and consultation in the EMEA activities.