בשל "הגנת זכויות יוצרים", מובא להלן קישור למאמר בלבד. לקריאתו בטקסט מלא, אנא פנה לספרייה הרפואית הזמינה לך.
Post-marketing drug safety evaluation in paediatrics is challenging because of differing drug pharmacokinetic and pharmacodynamic profiles compared with adults, uncertainty on the long-term drug risk-benefit profile and the additional risks due to off-label medicine use.
The Paediatric Regulation (EC) (No 1901/2006) was conceived and adopted by the European Medicines Agency (EMA) to address such challenges, identify research priorities and increase the volume and quality of paediatric research.
Several European regulatory milestones followed (Table 1), with the recently published Good Pharmacovigilance Practices (GVP) Chapter “Product- or Population-Specific Considerations IV: Paediatric population”, hereafter referred to as Paediatric GVP (PGVP), being the most recent. The PGVP was officially adopted in October 2018 after public consultation, aiming to improve the use of existing pharmacovigilance tools and procedures, while clarifying the role and...