OBJECTIVES To compare legislation on paediatric dosing guidelines and indications between the US and Europe and to examine whether the introduction of new regulations and financial incentives has resulted in more pharmaceutical companies providing paediatric data. METHODS Information was extracted from published policies and reports on paediatric therapeutics as published by the US Food and Drug Administration and the European Medicines Agency. RESULTS In the US, the Food and Drug Administration Modernisation Act (FDAMA; 1997) offered six months of marketing exclusivity to manufacturers voluntarily conducting paediatric studies. Current legislation in the US consists of the Best Pharmaceuticals for Children Act (BPCA; 2002), and the Paediatric Research Equity Act (PREA; 2003). Manufacturers are also encouraged to obtain orphan drug designation for drugs or biological products for use in a paediatric population. To January 2008, the FDA has sent written requests for paediatric studies to sponsors of 301 drugs. There have been 157 incidents of labeling changes under the BPCA and 76 labeling changes or submissions of supporting information under the PREA. Legislation on paediatric therapeutics was issued in the EU in January 2007 (Regulation (EC) No 1901/2006 as amended). Since this time, the EMEA has adopted decisions on 99 applications for paediatric investigational plans (PIPs) and waivers; 57 positive opinions on PIPs; 3 proposed modifications to PIPs; and 39 waivers in all age groups for all conditions. Additionally, most European Health Technology Assessment agencies do not make special allowances for the assessment of paediatric therapeutics and dosing. CONCLUSIONS The introduction of legislation in the US has been successful in encouraging research into the use of therapeutics in paediatric patients. In the EU, although many applications of PIPs and waivers have been reviewed, the situation should be monitored over the coming years to determine if the legislation leads to changes.