European Paediatric Regulation on drugs

Key words: European Paediatric Regulation, Medicinal products, Paediatric use, Drug development

The European Commission has produced a report on the experience gained in the application of Regulation (EC) No. 1901/2006 concerning medicinal products for paediatric use. Six years after the entry into force of the Regulation, the report describes the stages of its implementation, the results achieved, lessons learned and future prospects, taking into account the fact that, in view of the time required for drug development, not less than ten years will be needed to understand all the repercussions. The paper concludes with a note of optimism showing that: a) the development for paediatric use has become an integral part of the overall process of drug development in the EU; b) new medicines with paediatric indications and dosage forms appropriate to age groups have been approved; c) the large number of approved paediatric investigation plans indicates that other drugs are still being processed.