TEDDY NoE project in the framework of the EU Paediatric Regulation

Abstract

The lack of good quality medicines with formulations tailored for children and supported by properly conducted clinical trials or high level clinical evidence is a longstanding problem in Europe and worldwide. The adoption of the new Paediatric Regulation (Reg. 1901/2006/EC), which forces pharmaceutical industries to conduct a paediatric investigation plan (PIP), is expected to increase the availability of properly tested and authorised medicines for paediatric use. In this framework, the Task-force in Europe for Drug Development for the Young (TEDDY) Network of Excellence was established in 2005 to promote cooperation among researchers and other important stakeholders (regulatory authorities, professionals, patients and consumers) in order to optimise the paediatric use of current drugs and promote the development of new drugs for children, thus actively supporting the implementation of the European Paediatric Regulation.