MEDICINA ZA DECU: EVROPSKA INICIJATIVA ZA REGULISANJE NOVIH LEKOVA I KLINIČKIH STUDIJA

Abstract

Over the last two years, a special field named the “Medicine for Children” has been intensively developed. It is particularly significant for professionals, parents, but also for politicians and high-level officials of the European Union and its constitutive institutions: the European Health Commission and the European Council. The main idea is to make a drastic change in the attitude toward children, as the most vulnerable members of the society, namely to create the “Medicine for Children” instead of the “Medicine in Children”. This short report presents the draft and ideas of the new European legislation on the application of drugs for children, performance of clinical studies in paediatric population and mandatory inclusion into the international network of scientific experts, clinical centres capable of performing studies and the already completed or ongoing clinical study registers.

Keywords: children; drugs; clinical studies