Pharmaceutical Medicine

, Volume 33, Issue 1, pp 63–78 | Cite as



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).

Paediatric-specific guidance will be provided on all of the major pharmacovigilance tools and processes, including:
  • risk management plans (RMPs)

  • periodic safety update reports (PSURs)

  • po...

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© Springer Nature Switzerland AG 2019

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