The European Medicines Agency (EMA) has finalised their recently adopted guideline on good pharmacovigilance practices (GVP) module which provides recommendations for pharmacovigilance in paediatric populations.
The EMA notes that “adverse reactions to medicinal products in 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”. Medicines used to treat children may have different utilisation patterns and are frequently used off-label.
This module was adopted following a public consultation in 2017, and supersedes the 2007 guideline on the conduct of pharmacovigilance for medicines used in the paediatric population. Since the paediatric regulation came into force, changes in the scientific and regulatory environment have had direct consequences for pharmacovigilance in the paediatric population. Also, the number of paediatric medicines on the market, and in development have increased, and thus pharmacovigilance requirements have expanded.
The extended definition of adverse reaction now acknowledges the fact that adverse reactions may arise from the use of the product within or outside the terms of the marketing authorisation.
The guideline provides paediatric-focused recommendations for a number of pharmacovigilance processes, for example risk management plans, reporting age information, signal management, periodic safety update reports (PSURs) and safety communications. The functions of EMA and its Pharmacovigilance Risk Assessment Committee (PRAC) and Paediatric Committee (PDCO) are also described in the guidance.
To read the guideline on GVP product- or population-specific considerations IV: Paediatric population, please click here.