EMA gives guidance on safety monitoring of medicines used in children
EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises on how to adapt regulatory requirements to the paediatric population in the European Union.
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, i.e. for a medical purpose not in accordance with the terms of the marketing authorisation.
A dedicated approach to pharmacovigilance in children is especially important given that paediatric clinical trials are often limited in size and duration, and adverse reactions in children may substantially differ - in terms of frequency, nature, severity and presentation - from those occurring in adults.
The guidance focuses on aspects of pharmacovigilance of particular relevance to the use of medicines in children, such as off-label use and medication errors, and contains paediatric-specific guidance on all major pharmacovigilance tools and processes, including risk management plans, periodic safety update reports, post-authorisation safety studies, signal management and safety communication.
It also highlights the need to include comprehensive information in adverse drug reaction reports, such as the child’s age, weight and height, as well as, the indication or intention of use of the medicine, including its strength, dose and pharmaceutical form. This is important for all actors involved in safety reporting of medicines in children, including pharmaceutical companies, sponsors of clinical studies and regulatory authorities, but also parents/carers, healthcare professionals, patient and healthcare professional organisations, and organisations of national healthcare systems.
The new GVP chapter was finalised after careful consideration of the extensive feedback received during a public consultation, and replaces EMA’s human medicines committee’s (CHMP) 2007 guideline on conduct of pharmacovigilance for medicines used by the paediatric population.