EMA Issues Guideline on GVP Considerations for Pediatric Populations

Regulatory NewsRegulatory News | 07 November 2018 |  By 

The European Medicines Agency (EMA) on Wednesday released its recently adopted guideline on good pharmacovigilance practices (GVP) module providing recommendations for pharmacovigilance in pediatric populations.
Since the introduction of the EU’s new pharmacovigilance legislation in 2012, EMA has developed a series of GVP guidelines divided up into modules covering pharmacovigilance processes or product/population-specific considerations.
“Adverse reactions to medicinal products in the pediatric population need specific evaluation, as they may substantially differ – in terms of frequency, nature, severity and presentation – from those occurring in the adult population,” EMA writes, noting that medicines used to treat children often have “different utilization patterns and are often used off-label.”
This latest module was adopted following a public consultation in late 2017 and will supersede the 2007 Guideline on the Conduct of Pharmacovigilance for Medicines Used in the Pediatric Population when it goes into effect on Thursday.
"Since the Pediatric Regulation came into force, a number of changes in the scientific and regulatory environment have had direct consequences for the conduct of pharmacovigilance in the pediatric population," EMA writes.
Specifically, the number of pediatric medicines on the market and in development have increased and pharmacovigilance requirements have expanded.
"In particular, the extended definition of adverse reaction now acknowledges that adverse reactions may arise from use of the product within or outside the terms of the marketing authorization," the guideline states.
According to EMA, the recommendations in the guideline apply to medicines with a pediatric indication, authorized medicines with ongoing pediatric development and adult medicines "for which there is evidence of use in the pediatric population."
In addition to discussing the unique considerations for conducting pharmacovigilance activities for pediatric populations, the guideline provides pediatric-focused recommendations for various pharmacovigilance processes, such as risk management plans, reporting age information, signal management, periodic safety update reports (PSURs) and safety communication.
The guideline also covers various aspects of pharmacovigilance within the EU network, including functions of EMA and its Pharmacovigilance Risk Assessment Committee (PRAC) and Pediatric Committee (PDCO) as they relate to pediatric pharmacovigilance.
Guideline (with track changes), Comments


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