Regulatory efforts to protect children from harmful medicines began in the early 20th century. Political actions were first taken in the US in early 2000´s through the “Best Pharmaceuticals for Children Act (BPCA), and then in the EU through the Paediatric Regulation.
The Paediatic Regulation dramatically changed the regulatory environment for paediatric medicines in Europe. It´s main impact was the establishment of the Paediatric Committee (PDCO). PDCO is the expert organ of the European Medicines Agency evaluating the obligatory paediatric investigation plans (PIPs) that drug companies must present for new medicines or already marketed medicines with new indications.