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 “Pediatric Rule” (Best Pharmaceuticals for Children Act (BPCA)), and then in the EU through the Paediatric Regulation.
In the EU 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 and the Commission evaluating applications for marketing authorization of medicines for children in Europe. PDCO is also evaluating the obligatory paediatric investigation plans (PIPs) that drug companies must present for new medicines or already marketed medicines with new indications.
In Sweden clinical trials on humans are regulated by Swedish and EU regulations.