EMA guideline on GVP for paediatric population, effective from Nov.2018

EMA guideline on GVP for paediatric population, effective from Nov.2018

A new European Medicines Agency (EMA) guideline on Good Pharmacovigilance Practices (GVP) came into effect on 8 November 2018, providing recommendations for pharmacovigilance in paediatric populations.

Adverse reactions to medicinal products in the paediatric population need specific evaluation, as they may substantially differ – in terms of frequency, nature,  severity  and presentation – from those occurring in  the adult population. Additionally paediatric clinical trials are often limited in size and duration. Therefore, it is important with a dedicated approach to pharmacovigilance in children.

Collection of pharmacovigilance data should also take into account that in the paediatric population medicines have different utilisation patterns and are often used off-label, i.e. intentionally used for a medical purpose not in accordance with the terms of the marketing authorisation.

The EMA guideline provides guidance on how to make the best use of existing tools and processes to cover the specific needs and challenges in the safety monitoring of medicines for paediatric populations. It contains paediatric-specific guidance on all major pharmacovigilance tools and processes such as:

  • Risk Management Plans (RMP)
  • Periodic Safety Update Reports (PSUR)
  • Post-authorisation Safety Studies (PASS)
  • Signal management
  • Safety communication

The new guideline replaces the EMA Committee for Medicinal Products for Human Use 2007 guideline on the conduct of pharmacovigilance for medicines used in children.

Reference to the new EMA guideline on GVP for paediatric population:


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