Pharmaceutical companies in Europe will need to study the safety and effectiveness in children of certain medicines, which in the past were considered only relevant for adults. The European Medicines Agency’s Paediatric Committee (PDCO) has revised the current list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP).
The revisions will, hopefully, encourage companies to develop more new medicines for use in children. The current rules were not generating enough, or the right, studies in children, and this extensive revision aims to better balance the need to support development of medicines in children, avoiding at the same time exposing children to unnecessary studies. The changes mark a shift away from waivers that refer only to specific diseases which, says EMA, can mean overlooking the potential for the use of the medicines in children more generally. The revised rules are expected to come into effect in 2018.
More information