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EMA Releases Guidance for PV Monitoring in Paediatrics
A new Good Pharmacovigilance Practice (GVP) chapter is now available in the EU for safety monitoring of medicines used in children.
In a recent media release, the European Medicines Agency (EMA) noted that “the new GVP chapter covers approved medicines with a paediatric indication or with an ongoing paediatric development, but also medicines only approved for adults when they are used off-label to treat children”.
A dedicated approach to pharmacovigilance in this population is considered particularly important given that: (i) paediatric clinical trials are often smaller and shorter in duration; and (ii) adverse reactions in children can be considerably different to those seen in adults (i.e. in terms of frequency, nature, severity and presentation).
risk management plans (RMPs)
periodic safety update reports (PSURs)