| The quality and quantity of research into medicines intended to treat children is an oft-neglected concern. In a clarion call for change, Elisabethann Wright and Susan Clements at Hogan and Hartson investigate the new paediatric medicines regulation, which demands quality, safety and efficacy from medicinal products
It has been estimated that more than 50 per cent of medicines used to treat children in Europe have not been tested for use in this target group, neither have they been authorised for use in the care of children. On 26th January 2007, new EU legislation on medicines for children entered into force. The paediatric medicine regulation aims to balance the ethical issues raised by conducting trials on children with concerns arising from the treatment of children with products which have not been tested on them and the effects of which have not been assessed. The regulation plans to increase the development of medicines that are intended to treat children; to encourage research into medicines for use in treating children; and to improve the quality and quantity of information available in this area. It imposes an extensive system of requirements on companies and provides penalties for non-compliance. However, it also offers rewards and other incentives.
REQUIREMENTS
The regulation introduces the requirement that applications for marketing authorisation for new medicinal products include either the results of studies in the paediatric population that have been carried out in accordance with an agreed Paediatric Investigation Plan (PIP), or proof of having obtained a waiver or deferral from this obligation. |
