In December 2000, the European Parliament voted a resolution addressing the need for better medicines for children in Europe and asking the Commission to prepare a new regulation. Members of the European Parliament considered that there was indeed a health issue to be addressed and resolved at the EU level. Six years later, the EU regulation was published and entered into force on January the 26th, 2007. This European law is going to impact significantly access to new drugs for children with cancer. By considerably changing the landscape of drug development for children, the law will provide an opportunity to make further progress in the cure and quality of cure of children with cancer, at a time when truly innovative and effective anticancer drugs are becoming available. However, there are some risks and pitfalls that need to be anticipated and controlled in order to ensure that children will eventually benefit from the European initiative.