EU Paediatric Regulation (EU 1901/2006)
At the beginning of 2007, the Pediatric Regulation (EU 1901/2006) came into force in Europe. The aim of the regulation is to improve European children’s health by increasing pediatric clinical trials, development and marketing authorization of pediatric medicinal products, and by making information on pediatric medicinal products more readily available.
As a result, there will be more researched and safer medicines available for children in the future. The regulation puts the pharmaceutical industry under an obligation to investigate all new medicinal products designed for adults also on children and adolescents if they are regarded useful for the pediatric population. If a medicinal product is assessed likely to be ineffective or unsafe, or there is no clinical need for the product in pediatric population, drug regulatory authorities can issue a waiver.
Moreover, the results of already completed pediatric clinical trials and those of any future pediatric clinical trials must be publicly reported to competent authorities so that the pediatric population is not subjected to any unnecessary trials, and that already available results can be utilised.
Pediatric clinical trials are conducted only if the same scientific results cannot be obtained in any other way. Furthermore, these trials must be expected to have a direct benefit on the health of the patient, or their results can be expected to give particular benefits to a corresponding patient or age group.
Development of pediatric medicinal products is very challenging as medicinal products suitable for children should not contain any harmful supplements or additives and they should be in the form appropriate for children (e.g. minitablet, solution, lollipop, straw) so that they can be administered easily but also accurately. Moreover, the medicine should taste good enough so that the child is willing to take it.