Press Release: Stimulating the development of medicines for children

The European Medicines Agency’s Paediatric Committee (PDCO) revised in July 2015 the list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP).

These were seen to be the most extensive revisions to date, aimed at better balacing the need to support development of medicines in children with the goal of avoiding exposing children to unnecessary studies. The agency expected the revisions to encourage companies to develop more new medicines for use in children.

The revisions follow the PDCO’s review of the experience with class waivers since the Paediatric Regulation came into force in 2007.

Politico, 23.07.15: Europe to update rules on drug studies in kids http://www.politico.eu/article/europe-drug-kids-cancer-scientific/

---