Current Edition

EU Paediatric Investigation Plans (PIPs) and Clinical Studies in Children

Since 2007, new drugs need a paediatric investigation plan
(PIP) for EU registration. Without a PIP accepted by the
European Medicines Agency (EMA)’s paediatric committee
(PDCO), registration in adults and children is blocked. Klaus
Rose is an independent consultant, who advises on paediatric
drug development. In his article he talks about the paediatric
investigation plans.